Recalls / —
—#98988
Product
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
- FDA product code
- MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P030022
- Affected lot / code info
- 09FT32383, 09FT32504, 09GT33518, 09GT33519, 09GT33918, 09GT33919, 09GT34111, 09GT34112, 09KT36378, and 09MT38082
Why it was recalled
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.
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
Timeline
- Recall initiated
- 2011-03-11
- Posted by FDA
- 2011-04-22
- Terminated
- 2012-02-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #98988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.