Synthes (USA) Products LLC: Medical Device Recall in 2019 - (Recall #: Z-0349-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 5, 2019

Date Posted: November 20, 2019

Recall Number: Z-0349-2020

Event ID: 83991

Reason for Recall:

Modified outside of approved manufacturing process

Status: Terminated

Product Quantity: 9 units

Code Information:

Unknown

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated