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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Plates and Screws

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  Class 2 Device Recall Zimmer Plates and Screws see related information
Date Initiated by Firm May 04, 2016
Date Posted May 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall Number Z-1677-2016
Recall Event ID 73981
510(K)Number K112885  
Product Classification Screw, fixation, bone - Product Code HWC
Product Zimmer Plates and Screws (ZPS)
4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200
4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400
4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600
4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800
4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000
4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200
4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600
4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001
4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200
4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600
4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000
4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500
4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000
4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500
4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000
4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601
4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801
4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001
4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201
4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401
4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601
4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801
4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401
4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801
4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001
4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201
4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401
4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801
4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401
4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601
4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801
4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001
6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500
6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500
6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000
6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002
6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500
6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502
6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000
6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001
6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002
6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
Code Information LOTS: 63303573 63282072 63303577 63303574 63296633 63295456 63296634 63198636 63295464 63296636 63296638 63301486 63301487 63301489 63296639 63248519 63298802 63298803 63287869 63248522 63317364 63317363 63248525 63298795 63320881 63287871 63317168 63248527 63317167 63287874 63248531 63248532 63248535 63248537 63293690 63293693 63293694 63305250 63298784 63284871 63298783 63249226 63305251 63312141 
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall		 A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA Determined
Cause 2		 Packaging change control
Action All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Quantity in Commerce 3955
Distribution Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
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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