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

FDA device recall Z-2108-2023 · posted 2023-07-07 · Open, Classified

Recall details

Recalling firm

Osteomed, LLC

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

GWO

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.

Date initiated

2023-05-31

Date posted

2023-07-07

Location

Addison, TX

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