—#94545

Product

R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular Liner

FDA product code: KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083566
Affected lot / code info: All lots

Why it was recalled

The firm received reports of a femoral head popping out of the liner intraoperatively.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2010-08-13
Posted by FDA: 2010-10-18
Terminated: 2011-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94545. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.