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U.S. Department of Health and Human Services

Class 2 Device Recall R3 Constrained Acetabular Liner

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  Class 2 Device Recall R3 Constrained Acetabular Liner see related information
Date Initiated by Firm August 13, 2010
Date Posted October 18, 2010
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-0084-2011
Recall Event ID 56805
510(K)Number K083566  
Product Classification Prosthesis, hip, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
Product R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner
Code Information All lots
Recalling Firm/
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
Manufacturer Reason
for Recall
The firm received reports of a femoral head popping out of the liner intraoperatively.
FDA Determined
Cause 2
Action Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. 1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. 2) Identify customers that received these products and immediately notify them of the recall. 3) Carry out a physical count and record the data on the Verification Section included in the letter. 4) Contact their inventory specialist for an RA# and record this on the Verification Section. 5) Return the Verfication Section even if they do not have the recalled product. 6) Return the recalled product to: Smith & Nephew, Inc. Attn: Return Goods 3303 Holmes Road Memphis, TN 38118 Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010. For any questions regarding this recall customers were to call (901) 399-5441.
Quantity in Commerce 84 units
Distribution Worlwide Distribution, USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and WI and the countries of Australia and Portugal
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.