—#90078

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.

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K992348
Affected lot / code info: Catalog/Part number 462.725S. Lot number 6209477 exp 7/2018

Why it was recalled

potential compatibility issue

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide distribution: LA, MA, ME, NC, PA and VA.

Timeline

Recall initiated: 2010-02-25
Posted by FDA: 2010-05-07
Terminated: 2014-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.