Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Summary
The FDA issued a Class II for Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccess by Biomet, Inc.. Reason: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in exte.
Details
Source
Device Recall
External ID
Z-0382-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
Lot/Code Info: Lot Numbers/UDI: 331780 (01)00880304461680(17)270709(10)331780; 331790 (01)00880304461680(17)270726(10)331790; 331810 (01)00880304461680(17)270703(10)331810; 507020 (01)00880304461680(17)270724(10)507020; 507020R (01)00880304461680(17)270724(10)507020R; 608550 (01)00880304461680(17)271103(10)608550; 608700 (01)00880304461680(17)271030(10)608700; 671490 (01)00880304461680(17)271117(10)671490; 671850 (01)00880304461680(17)271102(10)671850; 857020 (01)00880304461680(17)271117(10)857020
Quantity Affected: N/A
Reason for Recall
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Distribution
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-09
Company
Warsaw, IN
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 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 clearances.
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 (Biomet, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomet, Inc. have FDA actions?
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0382-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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