Z-2108-2023Class II

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

Name: Z-2108-2023 REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Creator: Osteomed, LLC
Published: 2023-05-31
License: https://open.fda.gov/license/

Osteomed / initiated 2023-05-31 / Open, Classified / root cause: manufacturing process

FDA source

Osteomed, LLC began a recall of REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile on 2023-05-31. FDA classified it as Class II and gives the reason as "Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2108-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2023-07-07
Recalling firm: Osteomed
Product: REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Product code: GWO Plate, Cranioplasty, Preformed, Alterable
Reason for recall: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
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 codes and lots: Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-07
Z-2108-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-07

Product code GWO

K111176Class IIOsteomed Low Profile Neuro Fixation SystemOsteomed LP / cleared 2011-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)