Recall Z-1003-2014
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
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Codes / lots: 60879678 61278171 61625237 60564708 61026414 60564708R 60564710 60915347 61141512 61142759 60639474 60782037 62046409 60155294 60206463 62120939 60206463R 60108502 60152927 60206464 60862361 60862362 60862361R 60142899 60165580 60206466 60487350 60671954 60736748 61491355 62120941 60208478 60815946 61278172 61502705 60142901 60172569 60281392 60538633 60705043 60736749 60830649 61026415 60162132 60639475 60781210 61110037 60782040 60782041 61345993 61399023 61045321 61400219 60817011 61268917 60782042 60931208 61400222 61400223 61393376 60782043 61141513 61278174 61284322 61026411 61286935 60106612 60572988 61286938 61491356 60071404 60099545 60107375 60218931 60218932 60653031 60782044 61026409 61195093 61420626 61502706 61616173 60080046 60109509 60115145 60126996 60154170 60195018 60208481 60234047 60275162 60472815 60536817 60653032 60781212 60879681 61026406 61141514 61195094 61274845 61284324 61345995 61629793 61700052 60111966 60112840 60123244 60126997 60142902 60165583 60175627 60189035 60190841 60218933 60218934 60222827 60222828 60234048 60275163 60281396 60290741 60293063 60323238 60653043 60701995 60705044 60782045 60812141 60862367 61037587 61037588 61141515…
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-1003-2014
- Initiated
- October 11, 2013
- Posted by FDA
- February 20, 2014
- Terminated
- April 14, 2017
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 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-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-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 |