FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
- Recall number
- Z-0602-2008
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
- Status
- Terminated
- Initiated
- 2007-08-21
- Posted
- 2008-03-19
- Terminated
- 2012-05-09
- Reason
- Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Root cause
- Nonconforming Material/Component
- Action
- Smith & Nephew issued an Urgent Product Recall letter via Federal Express to User Facilities, Sales Reps and Distributors on 8/21/07. A second letter was issued on 8/23/07 to correct two errors in model numbers listed in the original letter. Letter issued by FedEx and/or email to OUS contacts.
- Quantity
- 2375 units
- Distribution
- Worldwide Distribution - USA, Austria. Belgium, Germany, Denmark, Spain, Finland, France, England, Italy, Portugal, Netherlands, Norway, New Zealand, Sweden, Turkey, Switzerland, China, Hong Kong, Malaysia, Taiwan, Singapore, Thailand, Australia, Canada, Mexico, Colombia, South Africa, Dubai, Venezuela, and Chile.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K051310"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- 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