Class 2 Device Recall Zimmer Periarticular Plating System

• Date Initiated by Firm: October 11, 2013
• Date Posted: February 20, 2014
• Recall Status: Terminated on April 14, 2017
• Recall Number: Z-1040-2014
• Recall Event ID: 66500
• 510(K)Number: K112885
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: PERI SCR. 3.5MM X 10MM ; PERI SCR. 3.5MM X 12MM ; PERI SCR. 3.5MM X 14MM ; PERI SCR 3.5MM X 44MM STE; PERI SCR. 3.5MM X 65MM ; PERI. SCR 4.0MM X24MM ; PERI. SCR 4.0MM X40MM ; PERI SCR. 4.0MMX14MM FULL; PERI SCR. 4.0MMX32MM FULL; PERI SCR. 4.0MMX38MM FULL; 3.5MM CORT SCR X 10MM ; 3.5MM CORT SCR X 12MM ; 3.5MM CORT SCR X 14MM ; 3.5MM CORT SCR X 16MM ; 3.5MM CORT SCR X 18MM ; 3.5MM CORT SCR X 20MM ; 3.5MM CORT SCR X 22MM ; 3.5MM CORT SCR X 24MM ; 3.5MM CORT SCR X 26MM ; 3.5MM CORT SCR X 28MM ; 3.5MM CORT SCR X 30MM ; 3.5MM CORT SCR X 32MM ; 3.5MM CORT SCR X 34MM ; 3.5MM CORT SCR X 36MM ; 3.5MM CORT SCR X 38MM ; 3.5MM CORT SCR X 40MM ; 3.5MM CORT SCR X 42MM ; 3.5MM CORT SCR X 44MM ; 3.5MM CORT SCR X 46MM ; 3.5MM CORT SCR X 48MM ; 3.5MM CORT SCR X 50MM ; 3.5MM CORT SCR X 52MM ; 3.5MM CORT SCR X 54MM ; 3.5MM CORT SCR X 56MM ; 3.5MM CORT SCR X 58MM ; 3.5MM CORT SCR X 60MM ; 3.5MM CORT SCR X 65MM ; 3.5MM CORT SCR X 70MM ; 3.5MM CORT SCR X 75MM ; 3.5MM CORT SCR X 80MM ; 3.5MM CORT SCR X 85MM ; 3.5MM CORT SCR X 90MM ; 3.5MM CORT SCR X 100MM ; 3.5MM CORT SCR X 105MM ; 3.5MM CORT SCR X 110MM ; CANC SCR 4.0MM X 10MM ; CANC SCR 4.0MM X 10MM FUL; CANC SCR 4.0MM X 12MM ; CANC SCR 4.0MM X 12MM FUL; CANC SCR 4.0MM X 14MM ; CANC SCR 4.0MM X 14MM FUL; CANC SCR 4.0MM X 16MM ; CANC SCR 4.0MM X 16MM FUL; CANC SCR 4.0MM X 18MM ; CANC SCR 4.0MM X 18MM FUL; CANC SCR 4.0MM X 20MM ; CANC SCR 4.0MM X 20MM FUL; CANC SCR 4.0MM X 22MM ; CANC SCR 4.0MM X 22MM FUL; CANC SCR 4.0MM X 24MM ; CANC SCR 4.0MM X 24MM FUL; CANC SCR 4.0MM X 26MM ; CANC SCR 4.0MM X 26MM FUL; CANC SCR 4.0MM X 28MM ; CANC SCR 4.0MM X 28MM FUL; CANC SCR 4.0MM X 30MM ; CANC SCR 4.0MM X 30MM FUL; CANC SCR 4.0MM X 32MM ; CANC SCR 4.0MM X 32MM FUL; CANC SCR 4.0MM X 34MM ; CANC SCR 4.0MM X 34MM FUL; CANC SCR 4.0MM X 36MM ; CANC SCR 4.0MM X 36MM FUL; CANC SCR 4.0MM X 38MM ; CANC SCR 4.0MM X 38MM FUL; CANC SCR 4.0MM X 40MM ; CANC SCR 4.0MM X 40MM FUL
• Code Information: 61337161 61251498 61251499 61220432 61553288 61966252 61966257 60856802 60871924 60871946 60837236 61168818 61168821 61251340 61168823 61251341 61168825 61216588 61247526 61168827 61216589 61247527 61168829 61216590 61247528 61168830 61216591 61247529 61168831 61247530 61168833 61216593 61247531 61168835 61247532 61168837 61216596 61247533 61168839 61168841 61168842 61168843 61168845 61247536 61168847 61223705 61168849 61168850 61168852 61168854 61168856 61168858 61168859 61168860 61168861 61168862 61567437 61411579 61678383 61678382 61835910 61835909 61214649 61216599 61214650 61216602 61251346 61216605 61591005 61190532 61190535 61740546 61190538 61190539 61401997 61190540 61190543 61560426 61823977 61190544 61190546 61740547 61190547 61190549 61740548 61190551 61190552 61560430 61190554 61190555 61560431 61190618 61190619 61740550 61190620 61190627 61560427 61190628 61190629 61401998 61190630 61190632 61740551 61190633 61190634 61740552 61190635 61190636 61740553 61190638 61190639 61190640 61190641 61190642 61740554 61190643
• 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: 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.