R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
This recall has been terminated (originally issued April 22, 2011).
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 11, 2011
- Posted
- April 22, 2011
- Terminated
- February 8, 2012
- Recall Number
- Z-2054-2011
- Quantity
- 325 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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
Lot / Code Info
09FT32385, 09FT32566, 09GT34366, 09GT34367, and 09HT34777
Root Cause
Employee error
Action Taken
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.