REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw… recallZ-2107-2023 · Osteomed, LLC · initiated May 31, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Osteomed, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

On June 6, 2023, OsteoMed/Acumed issued an "Urgent: Medical Device Recall" notification to affected consignees via FedEx Ground. OsteoMed/Acumed asked consignees to take the following actions: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1) Perform a physical count of your inventory. Identify any inventory of the lot number listed above that is still in its packaging. Locate and remove the affected, unopened, unused packages of screws, such that they are out of service (i.e., quarantined). 2) Record this data (product and quantity) on the survey found at the end of this letter (the Outstanding Field Action Survey). 3) Complete the remaining, applicable fields in the Outstanding Field Action Survey and either return it via email to [email protected] or a physical copy can be mailed to: OsteoMed/Acumed, Attn: Lauren Freytag- R23-002-TX, 3885 Arapaho Rd, Addison, TX 75001 4) If you have product to return, please contact [email protected] so that an appropriate return number and return instructions can be provided. 5) If you do not have product to return, you are still required to complete the form below. 6) For patients implanted with these affected devices, OsteoMed/Acumed advises physicians to monitor patients.

Recall details

Recall number: Z-2107-2023
Status: Open, Classified
Initiated by the company: May 31, 2023
Posted by the FDA: Jul 7, 2023
Recalling firm: Osteomed, LLC
Product code: GWO
FDA submissions: K111176
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 description

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

Code information (models, lots, serial numbers)

Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

OsteoMed 218-1604
Osteomed LLC · Plate, cranioplasty, preformed, alterable
1 recall6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92479).

Z-2108-2023 · Open, Classified
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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