Z-1549-2010

7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System...

Name: Z-1549-2010 7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System...
Creator: Synthes USA (HQ), Inc.
Published: 2010-02-25
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-02-25 / Terminated / root cause: design

FDA source

Synthes USA (HQ), Inc. began a recall of 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... on 2010-02-25. The reason FDA records is "potential compatibility issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1549-2010
Status: Terminated
Initiated: 2010-02-25
Posted: 2010-05-07
Terminated: 2014-10-20
Recalling firm: Synthes GmbH
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.
Product code: JDS Nail, Fixation, Bone
Reason for recall: potential compatibility issue
Root cause tag: design
FDA 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 should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at [email protected]. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.
Quantity in commerce: 5 units
Distribution: Nationwide distribution: LA, MA, ME, NC, PA and VA.
Product codes and lots: Catalog/Part number 462.725S. Lot number 6209477 exp 7/2018

Product code JDS

K992348Class IISynthes Spiral Blade for Humeral Nail (Sbhn)Synthes (Usa) / cleared 1999-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)