Recall Z-1285-2011 ยท KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Synthes USA (HQ), Inc.
02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
| Date | Feb 16, 2011 (initiated Oct 27, 2010) |
| Status | Terminated |
| Reason | Potential for out of specification star grind teeth. |
| Root cause | Other |
| Action | Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be take |
| Quantity | 24 |
| Distribution | Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM Synthes (Usa), Mar 20, 2008 |