FDA Medical Device Recalls (openFDA)
Osteomed, LLC: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
- Recall number
- Z-2107-2023
- Recalling firm
- Osteomed, LLC
- Product
- REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
- Status
- Open, Classified
- Initiated
- 2023-05-31
- Posted
- 2023-07-07
- Terminated
- not on file
- Reason
- Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- 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 Ellie.wood@acumed.net 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 Ellie.wood@acumed.net 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258
- 510(k) numbers
- ["K111176"]
- PMA numbers
- not on file
- Product code
- GWO
- Firm FEI
- 2027754
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28