Surgical Anchor Plug Devices Recalled for Potential Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend 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: FDA Class II device with a manufacturing defect that could prevent proper surgical function and extend operative time. No reported injuries, adverse events, or hospitalizations have been documented. This qualifies as a risk-of-harm situation without reported injury.
Plain-English summary
Biomet, Inc. is recalling the Compress Device Segmental Anchor Plug, 14 MM (Item Number 178404), used in orthopedic revision surgeries for failed osteotomies, arthrodesis procedures, and prior joint replacements.
The device may contain metal burrs in the transverse holes, which can prevent surgical drills or pins from passing through properly. This manufacturing defect could extend surgical time and complicate the procedure.
The recall affects devices distributed worldwide, including the United States, Canada, Australia, New Zealand, Japan, Netherlands, Argentina, and Chile. Affected lot numbers are identified by Biomet. Healthcare facilities and surgeons using these devices should immediately discontinue use of affected lots and contact Biomet for replacement devices.
The recalled product
- Product
- Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
- 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 (13)
- Lot Numbers/UDI 017900 (01)00880304002890(17)270912(10)017900
- 017900R (01)00880304002890(17)270912(10)017900R
- 240760 (01)00880304002890(17)270120(10)240760
- 332020 (01)00880304002890(17)270725(10)332020
- 332040 (01)00880304002890(17)270629(10)332040
- 608500 (01)00880304002890(17)270830(10)608500
- 608590 (01)00880304002890(17)271030(10)608590
- 609150 (01)00880304002890(17)270830(10)609150
- 671670 (01)00880304002890(17)271030(10)671670
- 712220 (01)00880304002890(17)270114(10)712220
- 752770 (01)00880304002890(17)270814(10)752770
- 798020 (01)0 0880304002890(17)270120(10)798020
- 965310 (01)00880304002890(17)271112(10)965310
Distribution
Distributed nationwide across the United States.
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