Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is classified as FDA Class II with no reported hospitalizations or injuries. The manufacturing defect creates a risk of harm to surgical patients through extended surgical time and potential complications. As a risk-of-harm product with no reported injury, it meets the High severity criterion.
Plain-English summary
Biomet, Inc. is recalling its Compress Device Segmental Anchor Plug (24 MM, Item Number 178414) due to a manufacturing defect involving metal burrs in the device's transverse holes.
The metal burrs prevent the surgical drill or pins from passing through the device as intended. This defect may result in the extension of surgical time during implantation procedures.
The recalled devices were distributed worldwide, including across the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. The specific lot numbers affected are 017930, 018070, 608560, 752820, and 752830.
Patients and healthcare providers with these devices should contact Biomet for guidance. Do not use any devices from the affected lot numbers.
The recalled product
- Product
- Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
- Manufacturer
- Biomet, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers/UDI 017930 (01)00880304259829(17)270702(10)017930
- 018070 (01)00880304259829(17)270629(10)018070
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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