Recall Z-2108-2023— Osteomed, LLC

Name: FDA recall Z-2108-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-31

Class II · Ongoing

Class II FDA medical device recall by Osteomed, LLC, initiated 2023-05-31. It names one FDA 510(k) clearance: K111176. Product: REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile. Reason: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole..

Recalling firm: Osteomed, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-31
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K111176 — OSTEOMED LOW PROFILE NEURO FIXATION SYSTEMOsteomed LP·cleared 2011-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

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