Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for

FDA device recall Z-2282-2013 · posted 2013-09-26 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.

Action taken

SYNTHES sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees examine their inventory, remove the recalled product from use and return them to Synthes. Customers were also instructed to completed the attached Verification Section at the end of the letter indicating whether or not they had any of the affected product and the number of devices found. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. For questions regarding this recall call 610-719-5000.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

27

Distribution

Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.

Date initiated

2013-01-11

Date posted

2013-09-26

Date terminated

2015-08-31

Location

West Chester, PA