Class 2 Device Recall R3 Constrained Acetabular Liner

• Date Initiated by Firm: August 13, 2010
• Date Posted: October 18, 2010
• Recall Status: Terminated on September 21, 2011
• Recall Number: Z-0081-2011
• Recall Event ID: 56805
• 510(K)Number: K083566
• Product Classification: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
• Product: R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular Liner
• Code Information: All lots
• Recalling Firm/ Manufacturer: Smith & Nephew Inc; 1450 E. Brooks Rd; Memphis TN 38116
• For Additional Information Contact: Victor Rocha; 901-399-6771
• Manufacturer Reason for Recall: The firm received reports of a femoral head popping out of the liner intraoperatively.
• FDA Determined Cause: Other
• 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: 89 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