Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

FDA device recall Z-0867-2017 · posted 2016-12-21 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Action taken

DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: Synthes5748@stericycle.com or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.

Root cause

Process control

Status

Terminated

Product code

FSM

Quantity affected

31 units

Distribution

Nationwide Distribution

Date initiated

2016-11-29

Date posted

2016-12-21

Date terminated

2017-08-03

Location

West Chester, PA