REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Summary
The FDA issued a Class II for REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Steri by Osteomed, LLC. Reason: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole..
Details
Source
Device Recall
External ID
Z-2108-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Lot/Code Info: Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006
Quantity Affected: N/A
Reason for Recall
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-31
Company
Addison, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Osteomed, LLC has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Osteomed, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Osteomed, LLC have FDA actions?
Osteomed, LLC has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2108-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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