Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 30 of 125
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Reason: Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The B...
Z-0988-2022 April 27, 2022 Sylmar, CA
Nextremity Solutions
Class II Terminated
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Z-0911-2022 April 20, 2022 Warsaw, IN
Nextremity Solutions
Class II Terminated
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Z-0913-2022 April 20, 2022 Warsaw, IN
Conformis, Inc.
Class II Completed
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Reason: Incorrect tibial base plate implant packaged in kit
Z-0899-2022 April 20, 2022 Billerica, MA
Nextremity Solutions
Class II Terminated
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Z-0912-2022 April 20, 2022 Warsaw, IN
Nextremity Solutions
Class II Terminated
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Z-0910-2022 April 20, 2022 Warsaw, IN
Nextremity Solutions
Class II Terminated
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Z-0914-2022 April 20, 2022 Warsaw, IN
Biomet, Inc.
Class II Terminated
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, ...
Reason: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic...
Z-0809-2022 March 30, 2022 Warsaw, IN
Biomet, Inc.
Class II Terminated
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient re...
Reason: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic...
Z-0811-2022 March 30, 2022 Warsaw, IN
Biomet, Inc.
Class II Terminated
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X...
Reason: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic...
Z-0812-2022 March 30, 2022 Warsaw, IN
Biomet, Inc.
Class II Terminated
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. ...
Reason: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic...
Z-0810-2022 March 30, 2022 Warsaw, IN
Nextremity Solutions
Class II Terminated
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Reason: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal ...
Z-0739-2022 March 16, 2022 Warsaw, IN
Nextremity Solutions
Class II Terminated
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Reason: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal ...
Z-0740-2022 March 16, 2022 Warsaw, IN
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0691-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0689-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0690-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0688-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0683-2022 March 9, 2022 Port Huron, MI
Stryker Leibinger GmbH & Co. KG
Class II Terminated
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Reason: Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus ...
Z-0715-2022 March 9, 2022 Freiburg Im Breisgau
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0687-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0682-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0686-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0685-2022 March 9, 2022 Port Huron, MI
BioPro, Inc.
Class II Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha...
Z-0684-2022 March 9, 2022 Port Huron, MI
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Reason: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the ...
Z-0658-2022 March 2, 2022 Yorba Linda, CA