FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
- Recall number
- Z-0581-2014
- Recalling firm
- Smith & Nephew Inc
- Product
- REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
- Status
- Terminated
- Initiated
- 2013-11-25
- Posted
- 2013-12-26
- Terminated
- 2017-02-01
- Reason
- One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
- Root cause
- Other
- Action
- All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall.
- Quantity
- 38 units
- Distribution
- Distributed in China and Spain.
- Lot, serial or model codes
- Batch No. 12BM04836
- 510(k) numbers
- ["K012787"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28