Biomet Compress Device Anchor Plug Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (20 MM) because metal burrs in transverse holes prevent surgical instruments from passing through, 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 a FDA Class II medical device with manufacturing defects (metal burrs) that prevent proper function during surgery. It qualifies as a risk-of-harm product where no injuries have been reported to date, matching the Score 3 criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling the Compress Device Short Anchor Plug (20 MM), Item Number 178562, a surgical implant device used in orthopedic procedures to correct unsuccessful osteotomy, arthrodesis, or previous joint replacement.
The recall was initiated because some units contain metal burrs in the transverse holes of the device. These burrs may prevent surgical drill bits or pins from passing through the holes as designed.
As a result, surgeons may encounter operational difficulties during surgery that could extend the duration of the procedure. The recalled units were distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand.
Healthcare facilities and surgeons who have received units from the affected lot numbers should contact Biomet for replacement units. The specific lot numbers affected include: 331820, 478000, 535420, 608710, 608740, 671500, 671510, and 857040.
The recalled product
- Product
- Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
- Manufacturer
- Biomet, Inc.
- Hazard
- metal-burrs
- obstruction
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 (8)
- Lot Numbers/UDI: 331820 (01)00880304461666(17)270710(10)331820
- 478000 (01)00880304461666(17)270629(10)478000
- 535420 (01)00880304461666(17)270826(10)535420
- 608710 (01)00880304461666(17)271114(10)608710
- 608740 (01)00880304461666(17)271113(10)608740
- 671500 (01)00880304461666(17)271030(10)671500
- 671510 (01)00880304461666(17)280121(10)671510
- 857040 (01)00880304461666(17)271112(10)857040
Distribution
Distributed nationwide across the United States.
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