Recall Z-1001-2014
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
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Codes / lots: 60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830 60962064 61107953 61144212 61291484 62326539 60137568 60381037 60452034 60678940 60725699 60861044 60885486 61030192 61064420 61107954 61144213 61291485 61627268 62320020 60099553 60124830 60155276 60210916 60279193 60293173 60406084 60678941 60735831 60772796 60820105 60914273 60932397 60962068 61100754 61107955 61141540 61383124 61542613 60099554 60123327 60151759 60165563 60186810 60218909 60323277 60337989 60392818 60641792 60700524 60776686 60861046 60885488 60914275 60932398 61041383 61064421 61107956 61122465 61383125 61523983 61549785 60097901 60151760 60167122 60231230 60242175 60338000 60374541 60678943 60690724 60700525 60820107 60863688 60962072 60997213 61041385 61099269 61107957 61122466 61162278 61185825 60097903 60151761…
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-1001-2014
- Initiated
- October 11, 2013
- Posted by FDA
- February 20, 2014
- Terminated
- April 14, 2017
- Product code
- HWC – Screw, Fixation, Bone
- 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-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-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 |