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U.S. Department of Health and Human Services

Class 2 Device Recall Profile 0 4mm AutoDrive Screw

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  Class 2 Device Recall Profile 0 4mm AutoDrive Screw see related information
Date Initiated by Firm May 31, 2023
Date Posted July 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2108-2023
Recall Event ID 92479
510(K)Number K111176  
Product Classification Plate, cranioplasty, preformed, alterable - Product Code GWO
Product REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Code Information Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006
Recalling Firm/
Manufacturer		 Osteomed, LLC
3885 Arapaho Rd
Addison TX 75001-4314
For Additional Information Contact Ellie Wood
972-677-4600
Manufacturer Reason
for Recall		 Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
FDA Determined
Cause 2		 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWO and Original Applicant = OSTEOMED L.P.
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