Recall Z-1015-2014
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
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
Codes / lots: 60123273 60132377 60140219 60141550 60142733 60148179 60155310 60165544 60186827 60195674 60200835 60216184 60220271 60220273 60226819 60252510 60252511 60259230 60262844 60264178 60281557 60291992 60311248 60336996 60351041 60366235 60379861 60389521 60445063 60463387 60517290 60517292 60530516 60564287 60581857 60581858 60581859 60581860 60674481 60674482 60714213 60714223 60714225 60714226 60857024 60857027 61019442 61516750 61616190 61635188 61685368 61771896 61899228 60094966 60098072 60123274 60124846 60145183 60150097 60155311 60167108 60175653 60185178 60194989 60199687 60207679 60216185 60220275 60223990 60226822 60230043 60242725 60252513 60255762 60262845 60264179 60281558 60281559 60311250 60322259 60336998 60351042 60373290 60377460 60385381 60463388 60517295 60539760 60564286 60564288 60581861 60581862 60581863 60581865 60592821 60609737 60642868 60653869 60714227 60714228 60714229 60714230 60714231 60741925 60857033 61129810 61186464 61473793 61730300 61771898 61842787 62025436 62029387 60094967 60103382 60132379 60135136 60141552 60167110 60175655 60179248 60195675 60220276 60252514 60281560 60281561 60311251 60353652 60391406 60440767 60452547 60564290 60581866…
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-1015-2014
- Initiated
- October 11, 2013
- Posted by FDA
- February 20, 2014
- Terminated
- April 14, 2017
- Product code
- NDF – Plate, 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-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-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 |