Compress Device Short Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.
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: FDA Class II surgical device with a manufacturing defect that could prolong surgery. No injuries or illnesses reported. This is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling Compress Device Short Anchor Plugs, 22 MM (Item Number 178564), used in orthopedic surgery for correction of unsuccessful osteotomy, arthrodesis, or revision of previous joint replacement. The devices are being recalled because they may contain metal burrs in the transverse holes, which can prevent the surgical drill or pins from passing through as intended.
If the burrs prevent proper passage of the drill or pins during surgery, the surgical procedure may need to be extended. No injuries or illnesses have been reported to date in connection with this recall.
The recall affects devices distributed worldwide, including the United States and internationally to Argentina, Australia, Canada, Chile, Japan, the Netherlands, and New Zealand. Seven specific lot numbers are involved in this recall: 441020, 535430, 577560, 577740, 608760, 671870, and 975160.
The recalled product
- Product
- Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
- Manufacturer
- Biomet, Inc.
- Hazard
- metal-burr
- 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 (7)
- Lot Numbers/UDI: 441020 (01)00880304461628(17)270915(10)441020
- 535430 (01)00880304461628(17)270701(10)535430
- 577560 (01)00880304461628(17)270725(10)577560
- 577740 (01)00880304461628(17)271114(10)577740
- 608760 (01)00880304461628(17)271112(10)608760
- 671870 (01)00880304461628(17)280131(10)671870
- 975160 (01)00880304461628(17)270806(10)975160
Distribution
Distributed nationwide across the United States.
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