—#119573

Product

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

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-06-11
Posted by FDA: 2013-08-12
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.