Biomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative 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 risk-of-harm product with a confirmed manufacturing defect that prevents proper device function during surgery. Though no injuries have been reported, the metal burrs increase operative time and associated surgical risks, meeting the criteria for High severity under FDA Class II classification.
Plain-English summary
Biomet, Inc. is recalling Compress Device Short Anchor Plugs, 18 MM (Item Number 178560), used in revision orthopedic surgeries for osteotomy correction, arthrodesis, and previous joint replacements. The devices have been identified as potentially containing metal burrs in the transverse holes.
During use, these metal burrs may prevent drill bits or pins from passing through the device, potentially extending the length of the surgical procedure. The devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand.
Facilities and healthcare providers with inventory of the affected lot numbers should be aware of this potential defect. Any suspected defects or reports of metal burrs should be reported to Biomet, Inc.
The recalled product
- Product
- Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
- Manufacturer
- Biomet, Inc.
- Hazard
- metal-burr
- instrument-obstruction
- surgical-delay
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: 331780 (01)00880304461680(17)270709(10)331780
- 331790 (01)00880304461680(17)270726(10)331790
- 331810 (01)00880304461680(17)270703(10)331810
- 507020 (01)00880304461680(17)270724(10)507020
- 507020R (01)00880304461680(17)270724(10)507020R
- 608550 (01)00880304461680(17)271103(10)608550
- 608700 (01)00880304461680(17)271030(10)608700
- 671490 (01)00880304461680(17)271117(10)671490
- 671850 (01)00880304461680(17)271102(10)671850
- 857020 (01)00880304461680(17)271117(10)857020
Distribution
Distributed nationwide across the United States.
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