3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation

FDA device recall Z-1800-2015 · posted 2015-06-15 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

Action taken

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers to advise them about the issue and associated risks. These accounts were asked to review inventory, immediately remove the affected lots that are still in the original packaging from stock, and to complete and return the response and return authorization forms. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes consultant.

Root cause

Employee error

Status

Terminated

Product code

HWC

Quantity affected

54

Distribution

Nationwide Distribution

Date initiated

2015-05-13

Date posted

2015-06-15

Date terminated

2016-08-18

Location

West Chester, PA

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