Recall Z-1549-2010
Synthes USA (HQ), Inc. · initiated February 25, 2010
Product
7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S 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 fractures with diaphyseal extension, and impending pathological fractures.
Codes / lots: Catalog/Part number 462.725S. Lot number 6209477 exp 7/2018
Reason for recall
potential compatibility issue
FDA-determined cause: Device Design
Action taken
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 should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at lewis.lynne@synthes.com. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.
Details
- Recall number
- Z-1549-2010
- Initiated
- February 25, 2010
- Posted by FDA
- May 7, 2010
- Terminated
- October 20, 2014
- Product code
- JDS – Nail, Fixation, Bone
- Quantity
- 5 units
- Distribution
- Nationwide distribution: LA, MA, ME, NC, PA and VA.
- Recalling firm
- Synthes USA (HQ), Inc., West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1548-2010 | 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium…potential compatibility issue | 02/25/2010Terminated |