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U.S. Department of Health and Human Services

Class 2 Device Recall Persona PS Conventional Articular Surfaces 14MM L 69CD

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 Class 2 Device Recall Persona PS Conventional Articular Surfaces 14MM L 69CDsee related information
Date Initiated by FirmMarch 17, 2016
Date PostedApril 06, 2016
Recall Status1 Terminated 3 on March 14, 2017
Recall NumberZ-1340-2016
Recall Event ID 73498
510(K)NumberK113369 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductPersona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Code Information lot 62646580
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall		The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
FDA Determined
Cause 2		Employee error
ActionDistributors, Sales Representatives, Operation Managers, and Hospital Risk Managers will be provided with an "Urgent Medical Device Recall-Lot Specific" letter.
Quantity in CommerceTBD
DistributionDistributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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