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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm April 15, 2016
Create Date June 10, 2016
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-1954-2016
Recall Event ID 73536
510(K)Number K980486  K983128  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product REV. SHELL LINER 0D 28X48 00700504828

REV. SHELL LINER 10D 28X50 00701005028

REV. SHELL LINER 10D 28X52 00701005228

REV. SHELL LINER 10D 28X54 00701005428

REV. SHELL LINER 10D 28X56 00701005628

REV. SHELL LINER 10D 28X58 00701005828

REV. SHELL LINER 10D 28X60 00701006028
REV. SHELL LINER 10D 28X62 00701006228
REV. SHELL LINE 10D 28X66 00701006628
REV. SHELL LINER 20D 28X48 00702004828
REV. SHELL LINER 20D 28X50 00702005028
REV. SHELL LINER 20D 28X52 00702005228
REV. SHELL LINER 20D 28X54 00702005428
REV. SHELL LINER 20D 28X56 00702005628
REV. SHELL LINER 20D 28X60 00702006028
REV. SHELL LINER 20D 28X62 00702006228
REV. SHELL LINER 20D 28X66 00702006628
Code Information 00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328 00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095 00701005228 REV. SHELL LINER 10D 28X52 61979218 00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039 00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094 00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434 00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046 00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380 00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740 00702004828 REV. SHELL LINER 20D 28X48 61987076 00702005028 REV. SHELL LINER 20D 28X50 61987075 00702005228 REV. SHELL LINER 20D 28X52 62102429 00702005428 REV. SHELL LINER 20D 28X54 62103435 00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329 00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155 00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867 00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact Product Service Department
973-576-0032
Manufacturer Reason
for Recall		 Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.
Quantity in Commerce 19,884 total
Distribution Nationwide and Foreign.
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 = JDI and Original Applicant = IMPLEX CORP.
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