FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
- Recall number
- Z-1929-2013
- Recalling firm
- Smith & Nephew Inc
- Product
- R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
- Status
- Terminated
- Initiated
- 2013-05-29
- Posted
- 2013-08-08
- Terminated
- 2016-03-22
- Reason
- One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
- Root cause
- Packaging process control
- Action
- All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.
- Quantity
- 53 units
- Distribution
- Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
- Lot, serial or model codes
- Batch No. 12FM00602
- 510(k) numbers
- ["K113848"]
- PMA numbers
- not on file
- Product code
- MBL
- 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