FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
- Recall number
- Z-1004-2009
- Recalling firm
- Smith & Nephew Inc
- Product
- Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
- Status
- Terminated
- Initiated
- 2008-11-21
- Posted
- 2009-04-21
- Terminated
- 2011-11-21
- Reason
- Liners measuring 28 mm ID and were mismarked as 32 mm.
- Root cause
- Process control
- Action
- All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
- Quantity
- 19 units
- Distribution
- International Distribution to Canada, France, Germany and Switzerland.
- Lot, serial or model codes
- Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.
- 510(k) numbers
- ["K991026"]
- 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