Z-0597-2008

Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Smith &...

Name: Z-0597-2008 Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Smith &...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2007-08-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-08-21 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 on 2007-08-21. The reason FDA records is "Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0597-2008
Status: Terminated
Initiated: 2007-08-21
Posted: 2008-03-19
Terminated: 2012-05-09
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
Product code: HWC Screw, Fixation, Bone
Reason for recall: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
Root cause tag: manufacturing process
FDA 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 in commerce: 6775 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.
Product codes and lots: All lots

Product code HWC

K051310Class IIPlc ScrewSmith & Nephew, Inc. / cleared 2005-07-26

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)