Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
Brand
Smith & Nephew, Inc. Endoscopy Division
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Smith & Nephew, Inc. Endoscopy Division is recalling Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, due to Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026