Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 68 of 125
Zimmer Biomet, Inc.
Class II Terminated
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Reason: One lot of humeral stem implants do not include the humeral bushing components.
Z-1239-2018 April 4, 2018 Warsaw, IN
Zimmer Dental Inc
Class II Terminated
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Z-1190-2018 April 4, 2018 Carlsbad, CA
Encore Medical, Lp
Class II Completed
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shou...
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500...
Z-1256-2018 April 4, 2018 Austin, TX
DePuy Orthopaedics, Inc.
Class II Terminated
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; ...
Reason: The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company...
Z-1219-2018 April 4, 2018 Warsaw, IN
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
SwishTapered Implant Intended for use in support for fixed bridgework.
Reason: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Z-1167-2018 March 28, 2018 Westlake Village, CA
OMNIlife science Inc.
Class II Terminated
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is inten...
Reason: The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external...
Z-1117-2018 March 28, 2018 Raynham, MA
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
SwishPlus Implant Intended for use in support for fixed bridgework.
Reason: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Z-1168-2018 March 28, 2018 Westlake Village, CA
Smith & Nephew, Inc.
Class II Terminated
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic ar...
Reason: The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Z-1105-2018 March 28, 2018 Memphis, TN
Zimmer Biomet, Inc.
Class II Terminated
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1023-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COM...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1036-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 637036...
Reason: Two lots of hip implants are mislabeled.
Z-0939-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1021-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients ...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1039-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1017-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1052-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1034-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1032-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX G...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1061-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous t...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1057-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1042-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1018-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1030-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX P...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1031-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1040-2018 March 21, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT...
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft...
Z-1050-2018 March 21, 2018 Warsaw, IN