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U.S. Department of Health and Human Services

Class 2 Device Recall CONSTRAINED LINER

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  Class 2 Device Recall CONSTRAINED LINER see related information
Date Initiated by Firm May 06, 2015
Date Posted June 09, 2015
Recall Status1 Terminated 3 on April 01, 2022
Recall Number Z-1735-2015
Recall Event ID 71330
510(K)Number K083566  
Product Classification Prosthesis, hip, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
Product R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO.

Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
Code Information Lot numbers: 14HM08235, 14KM08473 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Joe Metzger
901-396-2121
Manufacturer Reason
for Recall		 The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
FDA Determined
Cause 2		 Process change control
Action Smith & Nephew sent an Urgent-Product Recall Notification letter dated May 6, 2015. to Sales offices by E-mail and Hospitals via Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.
Quantity in Commerce 17 units
Distribution Worldwide Distribution - US Nationwide in the states of CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI and the countries of Australia, Switzerland, Chile, Canada, and Spain
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 = KWZ and Original Applicant = SMITH & NEPHEW, INC.
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