FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer
- Recall number
- Z-0961-2009
- Recalling firm
- Smith & Nephew Inc
- Product
- PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer
- Status
- Terminated
- Initiated
- 2008-11-21
- Posted
- 2009-02-03
- Terminated
- 2012-11-27
- Reason
- The product was breaking during use.
- Root cause
- Other
- Action
- All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.
- Quantity
- 51 units
- Distribution
- Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress
- Lot, serial or model codes
- Lot numbers: A55827, A59222, A62005, A62127, A62349, A63526, and A63779
- 510(k) numbers
- ["K081016"]
- PMA numbers
- not on file
- Product code
- KWS
- 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