Recall Z-0349-2020— Synthes (USA) Products LLC

Name: FDA recall Z-0349-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-05

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2019-09-05, terminated 2020-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle. Reason: Modified outside of approved manufacturing process.

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2019-09-05
Terminated: 2020-06-23
Firm location: West Chester, PA, United States

Product description

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle

Reason for recall

Modified outside of approved manufacturing process

Data sourced from openFDA. This site is unofficial and independent of the FDA.