Osteomed, LLC: Medical Device Recall in 2023 - (Recall #: Z-2108-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

Product Classification:

Class II

Date Initiated: May 31, 2023

Date Posted: July 19, 2023

Recall Number: Z-2108-2023

Event ID: 92479

Reason for Recall:

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Status: Ongoing

Product Quantity: N/A

Code Information:

Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

Voluntary or Mandated:

Voluntary: Firm initiated