FDA Device

R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis

Hazard

During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.

What You Should Do

Remedy

All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.

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Products

R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due
Brand
Smith & Nephew Inc
UPC
09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252

Units Affected

296 units

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