Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 96 of 125
Aesculap, Inc.
Class II Terminated
Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Reason: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patien...
Z-0423-2016 December 30, 2015 Center Valley, PA
BioHorizons Implant Systems Inc
Class II Terminated
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Reason: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Z-0391-2016 December 16, 2015 Hoover, AL
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patie...
Reason: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Z-0396-2016 December 16, 2015 Westlake Village, CA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostic...
Reason: Monitor Ceiling Suspension system may fall
Z-0348-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnost...
Reason: Monitor Ceiling Suspension system may fall
Z-0349-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Us...
Reason: Monitor Ceiling Suspension system may fall
Z-0346-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 ...
Reason: Monitor Ceiling Suspension system may fall
Z-0347-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnos...
Reason: Monitor Ceiling Suspension system may fall
Z-0350-2016 December 9, 2015 Andover, MA
Stryker Howmedica Osteonics Corp.
Class II Terminated
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adapto...
Reason: Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
Z-0362-2016 December 9, 2015 Mahwah, NJ
Carl Zeiss Meditec AG
Class II Terminated
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantati...
Reason: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Z-0357-2016 December 9, 2015 Jena
Merz North America, Inc.
Class II Terminated
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Z-0368-2016 December 9, 2015 Raleigh, NC
Merz North America, Inc.
Class II Terminated
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fo...
Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Z-0367-2016 December 9, 2015 Raleigh, NC
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnos...
Reason: Monitor Ceiling Suspension system may fall
Z-0354-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics...
Reason: Monitor Ceiling Suspension system may fall
Z-0352-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, ...
Reason: Monitor Ceiling Suspension system may fall
Z-0351-2016 December 9, 2015 Andover, MA
Merz North America, Inc.
Class II Terminated
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Z-0366-2016 December 9, 2015 Raleigh, NC
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnosti...
Reason: Monitor Ceiling Suspension system may fall
Z-0353-2016 December 9, 2015 Andover, MA
Medtronic Inc.
Class II Terminated
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Reason: Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Z-0342-2016 December 9, 2015 Saint Paul, MN
Covidien LLC
Class II Terminated
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodia...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0329-2016 December 2, 2015 North Haven, CT
Pega Medical Inc.
Class II Terminated
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. Th...
Reason: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Z-0324-2016 December 2, 2015 Laval, N/A
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chroni...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0331-2016 December 2, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apher...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0330-2016 December 2, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0333-2016 December 2, 2015 North Haven, CT
Alcon Research, Ltd.
Class I Terminated
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in th...
Reason: Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Z-0271-2016 December 2, 2015 Fort Worth, TX
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chroni...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0332-2016 December 2, 2015 North Haven, CT