Surgical implant anchor plugs may contain metal burrs affecting insertion
Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.
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 that can impede surgical function. The defect presents a risk of harm, but no injuries or adverse events have been reported, placing it at Score 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomet, Inc. is recalling Compress Device Short Anchor Plugs, 24 MM (Item Number 178566). These surgical implants are used in orthopedic procedures to correct revision failures, arthrodesis complications, or previous joint replacements.
The devices may contain metal burrs in the transverse holes. These burrs can prevent the surgical drill or pins from passing through the device during implantation, potentially requiring extension of the surgical procedure.
The recall affects Compress Device Short Anchor Plugs distributed nationwide in the United States as well as in Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. Specific lot numbers have been identified and are included in the recall notice.
Healthcare providers should inspect the devices before use and contact Biomet if they have questions about affected units. No injuries or adverse events have been reported in connection with this issue.
The recalled product
- Product
- Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
- 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 (11)
- Lot Numbers/UDI: 535440 (01)00880304461642(17)270803(10)535440
- 577570 (01)00880304461642(17)270726(10)577570
- 577590 (01)00880304461642(17)270802(10)577590
- 608770 (01)00880304461642(17)280201(10)608770
- 671520 (01)00880304461642(17)280131(10)671520
- 671530 (01)00880304461642(17)271026(10)671530
- 671880 (01)00880304461642(17)271114(10)671880
- 671880R (01)00880304461642(17)271114(10)671880R
- 735750 (01)00880304461642(17)271102(10)735750
- 735750R (01)00880304461642(17)271102(10)735750R
- 965240 (01)00880304461642(17)280113(10)965240
Distribution
Distributed nationwide across the United States.
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