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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution

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  Class 2 Device Recall NexGen Complete Knee Solution 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-1020-2014
Recall Event ID 66500
Product Classification Screw, fixation, bone - Product Code HWC
Product NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
Code Information 60114195 60595579 61077273 60187380 60610778 60796106 61137985 61249340 60105628 60595582 60919090 61277444 60330148 60732231 60945764 61283889 60219129 60579389 60756650 60965136 61207433 61242494 60244944 60579385 60756651 60965137 61233951 61593013 61887830 60105629 60166064 60224275 60244943 60337906 60461446 60586318 60595606 60696728 60808905 60906705 61018586 61103031 61180337 61249355 61341882 61422286 61526208 61636571 61717191 61770492 61887831 61929703 62048813 60213807 60331257 60579387 60941524 61233952 61687333 60099537 60139269 60194156 60244942 60330150 60436638 60614725 60681999 60838357 60945765 61089048 61207434 61378442 61585149 61770493 60105630 60191625 60200995 60610790 60858860 61180338 61770494 60139270 60209213 60310131 60579392 60713474 60906706 61089049 61378443 61902190 60503470 60678795 60897195 61233953 61770495 60124943 60230948 60420518 60676026 61056150 61445351 60177068 60330149 60504976 60671244 60897209 61146352 61770496 60294720 60503550 61018587 61585151 60233993 60501971 60834361 61160767 60105632 60503494 60586320 60595609 61238563 60125012 60504978 60844061 61265359 60266112 60503499 60860053 61207435 60209212 60382121 60491633 60671248 60847409 61070792 61238565 61497083 61911709 60099538 60395058 60503554 60682001 61228341 61266850 60160832 60367469 60503479 60858861 61207436 60310132 60491634 60671251 60991375 60105634 60139271 60213808 60330152 60461447 60652031 60861035 61180339 61422287 60135104 60194157 60266113 60334482 60436657 60503483 60667751 60834366 61146353 61445352 62143506 60125013 60213809 60330153 60503489 60965138 61504824 60177432 60263493 60503552 60858859 61331581 
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.
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