Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories a

FDA device recall Z-0348-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.

Action taken

Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.

Root cause

Device Design

Status

Terminated

Product code

HWE

Quantity affected

5

Distribution

Nationwide Distribution including the states of CO, LA, NY, and OK.

Date initiated

2011-10-17

Date posted

2011-12-02

Date terminated

2014-12-18

Location

West Chester, PA