Recall Z-0387-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
| Date | Nov 25, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. |
| Root cause | Process control |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: Our records indicate you received this product. Synthesis requesting that the product be returned: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product h |
| Quantity | 135 |
| Distribution | US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011857 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM Synthes (Usa), Sep 12, 2001 |