Recall Z-1010-2014
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
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Codes / lots: 60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782 60867785 61071422 61150075 61173568 61319435 61319436 61379514 60748952 60762088 60806399 60876899 60876901 60876902 61248174 61325065 60123303 60130220 60135214 60142918 60150073 60218846 60243102 60279663 60309141 60323311 60338439 60349093 60387528 60393392 60407659 60422612 60422615 60422617 60422618 60505967 60505968 60569960 60597683 60597684 60602462 60620369 60620371 60690750 60690751 60714161 60714162 60735662 60735663 60757051 60757052 60808010 60808011 60814567 60814568 60829596 60829597 60867787 60867788 60867789 60867790 60867792 60956540 60956547 61003994 61004003 61004006 61004010 61035979 61035980 61064854 61066610 61066611 61071425 61071426 61084123 61100815 61158640 61211625 61211626 61221436 61249859 61271267 61286461…
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-1010-2014
- Initiated
- October 11, 2013
- Posted by FDA
- February 20, 2014
- Terminated
- April 14, 2017
- Product code
- NDJ – Screw, Fixation, Bone, Non-Spinal, Metallic
- 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-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-1017-2014 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 |