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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Plates and Screws System/Zimmer Universal Locking System

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  Class 2 Device Recall Zimmer Plates and Screws System/Zimmer Universal Locking System see related information
Date Initiated by Firm October 11, 2013
Date Posted February 20, 2014
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-1042-2014
Recall Event ID 66500
510(K)Number k060710  K063303  K112885  
Product Classification Screw, fixation, bone - Product Code HWC
Product 1.5 X 6 CORT SCREW HEX/SE
2.0 X 6 CORT SCREW HEX/SE
2.0 X 10 CORT SCREW CRUCI
2.0 X 12 CORT SCREW CRUCI
2.0 X 14 CORT SCREW CRUCI
2.0 X 16 CORT SCREW HEX/S
2.0 X 16 CORT SCREW CRUCI
2.0 X 18 CORT SCREW CRUCI
2.0 X 20 CORT SCREW CRUCI
2.0 X 26 CORT SCREW CRUCI
2.0 X 28 CORT SCREW CRUCI
2.0 X 30 CORT SCREW CRUCI
2.0 X 32 CORT SCREW CRUCI
2.0 X 34 CORT SCREW CRUCI
2.0 X 36 CORT SCREW CRUCI
2.0 X 38 CORT SCREW CRUCI
2.0 X 40 CORT SCREW CRUCI
2.0 X 42 CORT SCREW CRUCI
2.0 X 44 CORT SCREW CRUCI
2.0 X 46 CORT SCREW CRUCI
2.0 X 48 CORT SCREW CRUCI
2.0 X 50 CORT SCREW CRUCI
2.7MM CORT. SCREW 6MM, ST
2.7MM CORT. SCREW 7MM, ST
2.7MM CORT. SCREW 8MM, ST
2.7MM CORT. SCREW 9MM, ST
2.7MM CORT. SCREW 10MM, S
2.7MM CORT. SCREW 12MM, S
2.7MM CORT. SCREW 14MM, S
2.7MM CORT. SCREW 16MM, S
2.7MM CORT. SCREW 18MM, S
2.7MM CORT. SCREW 20MM, S
2.7MM CORT. SCREW 22MM, S
2.7MM CORT. SCREW 24MM, S
2.7MM CORT. SCREW 26MM, S
2.7MM CORT. SCREW 28MM, S
2.7MM CORT. SCREW 30MM, S
2.7MM CORT. SCREW 32MM, S
2.7MM CORT. SCREW 34MM, S
2.7MM CORT. SCREW 36MM, S
2.7MM CORT. SCREW 38MM, S
2.7MM CORT. SCREW 40MM, S
2.7MM CORT. SCREW 42MM, S
2.7MM CORT. SCREW 44MM, S
2.7MM CORT. SCREW 45MM, S
2.7MM CORT. SCREW 46MM, S
2.7MM CORT. SCREW 48MM, S
2.7MM CORT. SCREW 50MM, S
2.7X52 CORT SCREW/SELFTAP
2.7X54 CORT SCREW/SELFTAP
2.7X55 CORT SCREW/SELFTAP
2.7X56 CORT SCREW/SELFTAP
2.7X58 CORT SCREW/SELFTAP
2.7X60 CORT SCREW/SELFTAP
2.7X65 CORT SCREW/SELFTAP
2.7X70 CORT SCREW/SELFTAP
3.5MM CORT. SCREW 10MM LN
3.5MM CORT. SCREW 12MM LN
3.5X14 CORT SCREW
3.5MM CORT. SCREW 14MM LN
3.5X16 CORT SCREW
3.5MM CORT. SCREW 16MM LN
3.5 X 16 SHAFT SCREW
3.5X18 CORT SCREW
3.5MM CORT. SCREW 18MM LN
3.5 X 18 SHAFT SCREW
3.5MM CORT. SCREW 20MM LN
3.5 X 20 SHAFT SCREW
3.5MM CORT. SCREW 22MM LN
3.5 X 22 SHAFT SCREW
3.5MM CORT. SCREW 24MM LN
3.5 X 24 SHAFT SCREW
3.5MM CORT. SCREW 26MM LN
3.5 X 26 SHAFT SCREW
3.5MM CORT. SCREW 28MM LN
3.5 X 28 SHAFT SCREW
3.5MM CORT. SCREW 30MM LN
3.5 X 30 SHAFT SCREW
3.5MM CORT. SCREW 32MM LN
3.5 X 32 SHAFT SCREW
3.5MM CORT. SCREW 34MM LN
3.5 X 34 SHAFT SCREW
3.5MM CORT. SCREW 36MM LN
3.5 X 36 SHAFT SCREW
3.5MM CORT. SCREW 38MM LN
3.5 X 38 SHAFT SCREW
3.5MM CORT. SCREW 40MM LN
3.5 X 40 SHAFT SCREW
3.5MM CORT. SCREW 45MM LN
3.5MM CORT. SCREW 50MM LN
3.5 X 50 SHAFT SCREW
3.5MM CORT. SCREW 55MM LN
3.5MM CORT. SCREW 60MM LN
3.5MM CORT. SCREW 65MM LN
3.5MM CORT. SCREW 70MM LN
3.5MM CORT. SCREW 75MM LN
3.5MM CORT. SCREW 80MM LN
3.5X85 CORT SCREW
3.5X90 CORT SCREW
3.5X95 CORT SCREW
3.5X100 CORT SCREW
3.5X105 CORT SCREW
3.5X110 CORT SCREW
3.5X115 CORT SCREW
3.5X120 CORT SCREW
3.5X125 CORT SCREW
3.5X130 CORT SCREW
3.5X135 CORT SCREW
3.5X140 CORT SCREW
3.5X145 CORT SCREW
3.5X150 CORT SCREW
4.0 X 10 CANCELL. SCREW
4.0 X 10 PART THD CANC SC
4.0 X 12 CANCELL. SCREW
4.0 X 12 PART THD CANC SC
4.0 X 14 CANCELL. SCREW
4.0 X 14 PART THD CANC SC
4.0 X 16 CANCELL. SCREW
4.0 X 16 PART THD CANC SC
4.0 X 18 CANCELL. SCREW
4.0 X 18 PART THD CANC SC
4.0 X 20 CANCELL. SCREW
4.0 X 20 PART THD CANC SC
4.0 X 22 CANCELL. SCREW
4.0 X 22 PART THD CANC SC
4.0 X 24 CANCELL. SCREW
4.0 X 24 PART THD CANC SC
4.0 X 26 CANCELL. SCREW
4.0 X 26 PART THD CANC SC
4.0 X 28 CANCELL. SCREW
4.0 X 28 PART THD CANC SC
4.0 X 30 CANCELL. SCREW
4.0 X 30 PART THD CANC SC
4.0 X 32 CANCELL. SCREW
4.0 X 34 CANCELL. SCREW
4.0 X 35 PART THD CANC SC
4.0 X 36 CANCELL. SCREW
4.0 X 40 CANCELL. SCREW
4.0 X 40 PART THD CANC SC
4.0 X 45 CANCELL. SCREW
4.0 X 45 PART THD CANC SC
4.0 X 50 CANCELL. SCREW
4.0 X 50 PART THD CANC SC
4.0 X 55 CANCELL. SCREW
4.0 X 55 PART THD CANC SC
4.0 X 60 CANCELL. SCREW
4.0 X 60 PART THD CANC SC
4.0 X 65 CANCELL. SCREW
4.0
Code Information 61267037 61195515 61233513 61255911 61196113 61255912 61255913 61196115 61233517 61255914 61255915 61255916 61196121 61196122 61759822 61196123 61582530 61605810 61196124 61582531 61196125 61196126 61582532 61196127 61759823 61196128 61196129 61196131 61196132 61196133 61196134 61196460 61196461 61168863 61234474 61196462 61196463 61234476 61247538 61196464 61225322 61234477 61196465 61234479 61168867 61196466 61234480 61196467 61234481 61196468 61234482 61196469 61234484 61168870 61196470 61168871 61196471 61196472 61168873 61196473 61168874 61196474 61196475 61168875 61196476 61168876 61196477 60654904 61168877 61196478 61196479 60654906 61196480 61168878 61196482 61196483 61196484 61168880 61196485 61256597 61256599 61256600 61256601 61256603 61310792 61344225 61530374 61654821 61256605 61256606 61216613 61247253 61557215 61881416 61216616 61247255 61263780 61585001 61247492 61247493 61251362 61251363 61322883 61326924 61473762 61873515 61247496 61247272 61247273 61247275 61775835 61835769 61196225 61247504 61247505 61241617 61337168 61339774 61775836 61196226 61247277 61263781 61263782 61263783 61196227 61234462 61247278 61263784 61196228 61263785 61196229 61247280 61263786 61196230 61234465 61263787 61640844 61775837 61196231 60619377 61216644 61234466 61196232 61216646 61234467 61196233 61585002 61196234 61216649 61296496 61196235 60619404 61216651 61635840 61196236 61234469 61420532 61614769 61196237 61216653 61234470 61585003 61640846 61234471 61640847 61196239 60619379 61216656 60619382 60564048 60619380 61216659 61234473 60564052 60553867 60564055 60619373 60564056 60619372 61196212 61196213 61196214 61196215 61196216 61196217 61196218 61196219 61196220 61196221 61196222 61196223 61196224 61251335 61378853 61296498 61359796 61553346 61574969 61216664 61234486 61296499 61420534 61234487 61234488 61247467 61263788 61234489 61234491 61567476 61247468 61378854 61447036 61553315 61565530 61567477 61234505 61241624 61234494 61420533 61473763 61557223 61268670 61268671 61557234 61251336 61553318 61593247 61263789 61216671 61234496 61553324 61263790 61553354 61216672 61234497 61234507 61234498 61359797 61557240 61337169 61234508 61553360 61574970 61359792 61557227 61234499 61296492 61553325 61567479 61234509 61337170 61339782 61574968 61234500 61337171 61553337 61567481 61597163 61234510 61234511 61241623 61247481 61251337 61234512 61234513 61216677 61234502 61234514 61234515 61247475 61473764 61567482 61231084 61231085 61231088 61378855 61231091 61231093 61369555 61567484 61231095 61231097 61567485 61231108 61359794 61553343 61359795 61854115 61251502 61225496 61251503 61251504 61225498 61225503 61247289 61225576 61225505 61225510 61251507 61251508 61225513 61251509 61251514 61247293 61225578 61251517 61251520 61225542 61225543 61225544 61225547 61237540 61225549 61225551 61225552 61251532 61251533 61251535 61553371 61553376 61337178 61225599 61225601 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer 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 2		 Packaging
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ZIMMER, INC.
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