Biomet Compress Anchor Plugs Recalled for Metal Burrs in Transverse Holes
Biomet is recalling Compress Device Segmental Anchor Plugs (18 MM) due to metal burrs in transverse holes that may prevent proper drill or pin placement, potentially extending surgery time.
What this means for you
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 an FDA Class II recall of a surgical device with a manufacturing defect (metal burrs) that creates a risk of harm by potentially extending surgery time and requiring revision procedures. No injuries or illnesses have been reported, placing this in the 'High' severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling Compress Device Segmental Anchor Plugs (18 MM, Item Number 178408) used in orthopedic surgical procedures for bone reconstruction and revision surgeries, including correction of unsuccessful osteotomies, arthrodeses, and previous joint replacements.
The recalled devices may contain metal burrs in their transverse holes. These burrs can prevent the surgical drill or pins from passing through the device as intended, potentially extending the duration of surgery and requiring additional procedures.
The affected devices were distributed worldwide, including to the United States and the countries of Argentina, Australia, Canada, Chile, Japan, Netherlands, and New Zealand. Affected lot numbers are specified in the official FDA recall notice.
Healthcare providers should inspect devices before use and contact Biomet if they identify affected devices or experience any complications. Patients who may have received these devices should contact their healthcare provider if they have concerns about their surgical procedure.
The recalled product
- Product
- Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
- Manufacturer
- Biomet, Inc.
- Hazard
- metal-burr
- surgical-complication
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 (10)
- Lot Numbers/UDI: 017910 (01)00880304259768(17)270807(10)017910
- 017910R (01)00880304259768(17)270807(10)017910R
- 018060 (01)00880304259768(17)270817(10)018060
- 332060 (01)00880304259768(17)270817(10)332060
- 608610 (01)00880304259768(17)271204(10)608610
- 671740 (01)00880304259768(17)271117(10)671740
- 671740R (01)00880304259768(17)271117(10)671740R
- 752790 (01)00880304259768(17)270816(10)752790
- 752790R (01)00880304259768(17)270816(10)752790R
- 965290 (01)00880304259768(17)271030(10)965290
Distribution
Distributed nationwide across the United States.
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