Compress Device Anchor Plugs recalled due to metal burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drill or pins from passing through, potentially extending surgical time.
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 is a medical device with a manufacturing defect that prevents proper function during surgical use. The metal burrs blocking the transverse holes create a risk of surgical complications, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling Compress Device Segmental Anchor Plugs (Item Number 178402, 12 MM) used in orthopedic surgery for correction and revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
The recalled devices may contain metal burrs in the transverse holes. These burrs can prevent the drill or pins from passing through the device during surgical placement, potentially extending surgical time and complicating the procedure.
The affected devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. The recall involves multiple lot numbers of the product.
Healthcare facilities and surgeons in possession of affected Compress Device Anchor Plugs should contact Biomet, Inc. regarding this recall. Patients who have had these devices implanted should consult with their healthcare provider regarding their implant.
The recalled product
- Product
- Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
- Manufacturer
- Biomet, Inc.
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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