Z-0381-2024 Class II Ongoing
FDA device recall Z-0381-2024 was initiated by Biomet, Inc. on Oct 9, 2023 and is designated Class II. 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 The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2023
- Initiation Date
- Oct 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
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 Pattern
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
Code Information
Lot Numbers/UDI: 331750 (01)00880304461673(17)270726(10)331750; 331760 (01)00880304461673(17)270725(10)331760; 331770 (01)00880304461673(17)270901(10)331770; 577380 (01)00880304461673(17)270725(10)577380; 608690 (01)00880304461673(17)271030(10)608690; 671340 (01)00880304461673(17)271026(10)671340; 671350 (01)00880304461673(17)271127(10)671350; 671460 (01)00880304461673(17)271030(10)671460; 671840 (01)00880304461673(17)271117(10)671840; 735690 (01)00880304461673(17)271030(10)735690; 735720 (01)00880304461673(17)271109(10)735720; 735720R (01)00880304461673(17)271109(10)735720R; 930750 (01)00880304461673(17)270726(10)930750
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0381-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026