Recall Z-0608-2008 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
| Date | Mar 19, 2008 (initiated Aug 21, 2007) |
| Status | Terminated |
| 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 | 2357 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, Venez |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051310 | PLC SCREW Smith & Nephew, Inc., Jul 26, 2005 |