Device recall: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

FDA enforcement event 92479 · Class II · initiated 31 May 2023 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsAddison, TX

Osteomed, LLC (Addison, TX) initiated this device recall on 31 May 2023; FDA lists 2 product records under event 92479, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Osteomed, LLC has 3 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Osteomed, LLC, Addison, TX.

Reason for recall

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

Distribution

"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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2107-2023	REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile	N/A	Class II	Ongoing	19 Jul 2023
Z-2108-2023	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile	N/A	Class II	Ongoing	19 Jul 2023

Context

88%of 2023 device events are Class II917 events that year

2product records in this eventfirm median: 2

3events on this register for the firm

Other enforcement events for Osteomed, LLC

Initiated	Product (first record)	Type	Class	Records
28 Oct 2021	OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Consol	Device	Class II	1
2 Apr 2020	OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void fil	Device	Class II	12

All 3 events for Osteomed, LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.