Recall Z-1006-2014

Zimmer, Inc. · initiated October 11, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980, 001981, 0011990 and 0011991

Codes / lots: 60053473 60528659 60807849 60855076 365855 60807850 60855077 365856 60143351 60384033 60403721 60452546 60543211 60632720 60807851 368913 369123 60219007 60740783 60993433 365857 369559 371074 60539739 60807852 365859 60098398 60119108 60241936 60625494 60082810 60625506 365860 365861 60222477 60109715 60187232 366023 60161891 60116180 60175536 365749 60082811 60109716 60123966 60175537 60231394 60097992 60119110 60123967 60143352 60154511 60165702 60175538 60231395 365740 366424 60109717 60112053 60112054 60116181 60116182 60119111 60119112 60129316 60129317 60154512 60154513 60165703 60175539 60187233 60187234 60206858 60206859 60241934 60161892 365739 60109718 365738 60123968 366024 366025 60136407 365752 365751 60123969 60154514 60082812 60109719 365753 365743 60163222

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-1006-2014
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1001-2014 Class IIMagna-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 IIHERBERT 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 IIFREE-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 IIItem 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 IIVERSA-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-1007-2014 Class IIM/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 IIRECON 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 IIINTERLOCKING 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 IIINTERLOCKING 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 IIM/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 IIASIA 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 IIITST 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 IIONE-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 IIDISTAL 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 IIMOORE 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 IIMOORE 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 IIMODULAR 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 IIBipolar 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 IINEXGEN 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 III/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 IINEXGEN 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 IIMODULAR 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 IITRILOGY 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 IIHGP 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 IIHGP 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 IIPRESSFIT 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 IIVERSYS 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 II12/14 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 IIZIMTRON 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 II12/14 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