Recall Z-1548-2010 ยท JDS Nail, Fixation, Bone
Synthes USA (HQ), Inc.
7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral f
| Date | May 7, 2010 (initiated Feb 25, 2010) |
| Status | Terminated |
| Reason | potential compatibility issue |
| Root cause | Device Design |
| Action | The recalling firm, Synthes, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they shou |
| Quantity | 1 unit |
| Distribution | Nationwide distribution: LA, MA, ME, NC, PA and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992348 | SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) Synthes (Usa), Sep 23, 1999 |