Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

FDA device recall Z-1952-2013 · posted 2013-08-12 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

Action taken

Sythes notified direct accounts by letter on 6/11/13 and requested them to check their inventory and remove affected lots from stock. Synthes requested that affected lots be returned and to call Synthes at 1-800-479-6329 for a Return Authorization Number. Completion and return of the Verification section at the end of the letter was requested, including negative responses.

Root cause

Device Design

Status

Terminated

Product code

HTO

Quantity affected

13,050

Distribution

Nationwide Distribution.

Date initiated

2013-06-11

Date posted

2013-08-12

Date terminated

2015-08-31

Location

West Chester, PA