Recall Z-1017-2014
Zimmer, Inc. · initiated October 11, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
Codes / lots: 60204970 60242926 60877896 61059555 60148524 60162051 60187879 61178682 365451 60097214 60097216 60313377 60395244 60441594 60484309 60540466 60609930 60768532 60979646 61003342 61029820 61135862 61307977 61575440 369866 60087317 60097220 60172931 60187880 60242928 60242933 60293228 60335340 60395248 60422523 60484314 60540516 60609935 60743728 60864758 60877921 60919578 61102981 61135863 61262147 61262148 61336941 61575443 61575444 367763 60120648 60124981 60172935 60187881 60326524 60335353 60370152 60411948 60441627 60532104 60581829 60726774 60787322 60900086 60960054 61003345 61122115 61179463 61262149 61387146 61575446 61596750 365457 366212 369774 60064812 60095554 60095560 60134404 60154918 60187882 60204978 60242941 60242942 60260213 60335392 60335393 60370158 60395262 60411955 60411956 60484366 60484367 60501914 60532123 60540536 60609996 60678493 60727909 60727910 60743735 60787899 60887298 60900087 61003347 61012722 61081371 61122116 61158989 61179459 61262150 61304671 61318408 61329737 61339783 61387149 61501412 61565711 61575452 60095693 60095694 60204979 60260220 60293281 60395267 60423089 60484383 60532144 60574503 61003348 61003349 61029828 61118583 61122119…
Reason for recall
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA-determined cause: Packaging
Action taken
Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
Details
- Recall number
- Z-1017-2014
- Initiated
- October 11, 2013
- Posted by FDA
- February 20, 2014
- Terminated
- April 14, 2017
- Product code
- JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal
- Quantity
- 7,044,680 total
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1001-2014 Class II | Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1002-2014 Class II | HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1003-2014 Class II | FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1004-2014 Class II | Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1005-2014 Class II | VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1006-2014 Class II | VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1007-2014 Class II | M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1008-2014 Class II | RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1009-2014 Class II | INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1010-2014 Class II | INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1011-2014 Class II | M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1012-2014 Class II | ASIA ONE-PIECE LAG SCREWZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1013-2014 Class II | ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM)…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1014-2014 Class II | ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1015-2014 Class II | DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1016-2014 Class II | MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1018-2014 Class II | MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1019-2014 Class II | Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1020-2014 Class II | NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1021-2014 Class II | I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1022-2014 Class II | NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1023-2014 Class II | MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1024-2014 Class II | TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1025-2014 Class II | HGP II ACETABULAR CUP BONZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1026-2014 Class II | HGP II ACETABULAR CUP MODZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1027-2014 Class II | PRESSFIT FEM ST FX 16 X 1Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1028-2014 Class II | VERSYS HERITAGE FEM STEMZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1029-2014 Class II | 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1030-2014 Class II | ZIMTRON 6 DEG 22 HEADSZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |
| Z-1031-2014 Class II | 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | 10/11/2013Terminated |