Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 88 of 125
Zimmer Biomet Spine, Inc
Class II Terminated
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Reason: Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the imp...
Z-2397-2016 August 17, 2016 Broomfield, CO
Zimmer Gmbh
Class II Terminated
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Reason: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschn...
Z-2322-2016 August 10, 2016 Winterthur
Zimmer Gmbh
Class II Terminated
TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Reason: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschn...
Z-2321-2016 August 10, 2016 Winterthur
Teleflex Medical
Class II Terminated
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which t...
Reason: The manufacturing and expiration dates are not printed on the blister pack label.
Z-2327-2016 August 10, 2016 Morrisville, NC
Zimmer Gmbh
Class II Terminated
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Reason: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschn...
Z-2324-2016 August 10, 2016 Winterthur
Mentor Texas, LP.
Class II Terminated
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Reason: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Z-2326-2016 August 10, 2016 Irving, TX
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
RePlant¿ Angled Abutment Part Number 6050-52-60
Reason: Issue with design specification; oversized condition.
Z-2320-2016 August 10, 2016 Westlake Village, CA
Zimmer Gmbh
Class II Terminated
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Reason: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschn...
Z-2323-2016 August 10, 2016 Winterthur
Zimmer Gmbh
Class II Terminated
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joi...
Reason: Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for del...
Z-2292-2016 August 3, 2016 Winterthur, N/A
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw a...
Reason: Incorrect top label on an implant package.
Z-2237-2016 July 27, 2016 Yorba Linda, CA
Biomet, Inc.
Class II Terminated
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variet...
Reason: The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue ir...
Z-2240-2016 July 27, 2016 Warsaw, IN
Synthes (USA) Products LLC
Class II Terminated
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditiona...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2189-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist ...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2199-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments ar...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2193-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are us...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2190-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2191-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used ...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2195-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional In...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2192-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2198-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditi...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2197-2016 July 20, 2016 West Chester, PA
Synthes (USA) Products LLC
Class II Terminated
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. ...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2196-2016 July 20, 2016 West Chester, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II Terminated
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2...
Reason: This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting ...
Z-2200-2016 July 20, 2016 Mounds View, MN
Synthes (USA) Products LLC
Class II Terminated
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR condi...
Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM sta...
Z-2194-2016 July 20, 2016 West Chester, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II Terminated
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care ...
Reason: Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents...
Z-2125-2016 July 13, 2016 Mounds View, MN
Integra LifeSciences Corp.
Class II Terminated
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for moveme...
Reason: As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the materi...
Z-2086-2016 July 6, 2016 Plainsboro, NJ