7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intende

FDA device recall Z-1548-2010 · posted 2010-05-07 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

potential compatibility issue

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.

Root cause

Device Design

Status

Terminated

Product code

JDS

Quantity affected

1 unit

Distribution

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

Date initiated

2010-02-25

Date posted

2010-05-07

Date terminated

2014-10-20

Location

West Chester, PA

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