R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D.… recallZ-2057-2011 · Smith & Nephew Inc · initiated Mar 11, 2011
Terminated All recalls posted in April 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2057-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 11, 2011
- Posted by the FDA
- Apr 22, 2011
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 449 units
- Product code
- MRA
- FDA submissions
- P030022
- 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
Product description
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Code information (models, lots, serial numbers)
09DT30917, 09ET31916, 09ET31977, 09FT32386, 09FT32854, 09GT33389, 09GT33893, 09GT33894, 09HT34767, 09HT34768, 09HT34769, and 09JT35381
Other devices under the same FDA submission
12 devices cleared under P030022 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- R3 ACETABULAR 71338954Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented9 reports
- R3 ACETABULAR 71338952Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented7 reports
- R3 ACETABULAR 71338950Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- R3 ACETABULAR 71338956Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- BIOLOX FORTE CERAMIC 71330284Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- BIOLOX FORTE CERAMIC 71332084Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- R3 ACETABULAR 71338948Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- BIOLOX FORTE CERAMIC 71332085Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- BIOLOX FORTE CERAMIC 71330280Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- REFLECTION 71332056Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- REFLECTION 71338456Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- R3 ACETABULAR 71338958Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 58324).
- Z-2053-2011 · TerminatedR3 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 …
- Z-2054-2011 · TerminatedR3 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
- Z-2055-2011 · TerminatedR3 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
- Z-2056-2011 · TerminatedR3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
- Z-2058-2011 · TerminatedR3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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