DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

FDA device recall Z-1912-2016 · posted 2016-06-06 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

Action taken

Depuy Synthes sent an Urgent Notice: Medical Device Recall letter on 05/02/2016 to all affected consignees. Consignees were instructed to do the following: review your inventory immediately to see if any of the affected products were being stored, and call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement order, to complete the Verification Section (page 3) and return with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.

Root cause

Process design

Status

Terminated

Product code

HTO

Quantity affected

244 units

Distribution

US nationwide distribution.

Date initiated

2016-05-02

Date posted

2016-06-06

Date terminated

2016-12-13

Location

West Chester, PA