Synthes (USA) Products LLC: Medical Device Recall in 2019 - (Recall #: Z-0223-2020)

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:

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

Product Classification:

Class II

Date Initiated: September 16, 2019

Date Posted: November 6, 2019

Recall Number: Z-0223-2020

Event ID: 83948

Reason for Recall:

The subject product measures 4.0mm in diameter instead of 3.5mm.

Status: Terminated

Product Quantity: 6

Code Information:

10L2702

Distribution Pattern:

Distributed to NJ.

Voluntary or Mandated:

Voluntary: Firm initiated