Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0126-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

Product Classification:

Class II

Date Initiated: September 21, 2015

Date Posted: October 21, 2015

Recall Number: Z-0126-2016

Event ID: 72243

Reason for Recall:

Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

Status: Terminated

Product Quantity: 793

Code Information:

Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated