| Class 2 Device Recall CONSTRAINED LINER | |
Date Initiated by Firm | May 06, 2015 |
Date Posted | June 09, 2015 |
Recall Status1 |
Terminated 3 on April 01, 2022 |
Recall Number | Z-1736-2015 |
Recall Event ID |
71330 |
510(K)Number | K083566 |
Product Classification |
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
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Product | R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, 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: 14JM02623 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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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 | 0 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWZ
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