Recall Z-1821-2009 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker Howmedica Osteonics Corp.
Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.
| Date | Aug 18, 2009 (initiated Jun 18, 2009) |
| Status | Terminated |
| Reason | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. |
| Root cause | Process control |
| Action | Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions. |
| Quantity | 13 total, (both products) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872224 | MODIFIED TROCHANTER CABLE GRIP SYSTEM Howmedica Corp., Aug 17, 1987 |