Biomet Trauma Surgical Instruments Recalled Due to Packaging Defect

Plain-English summary

Biomet, Inc. is recalling various TRAUMA Drill Bits, Taps, and Guide Pins (2,594 units across 44 lots) due to a packaging defect that may compromise sterile barrier integrity.

When surgical instrument packaging fails to maintain sterile barrier, the instruments may become contaminated before use, creating a risk of surgical site infection and potential need for additional surgical intervention.

The affected products were distributed worldwide, including to healthcare facilities in 28 U.S. states (Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington, and Wyoming), as well as Australia, Japan, and the Netherlands.

Healthcare providers who have received the recalled products should contact Biomet, Inc. for recall guidance and should examine whether any of the affected lots have been used in procedures.

The recalled product

Product

BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill B

Manufacturer

Biomet, Inc.

Category

Medical Device — Surgical Instruments

Hazard

• packaging-defect
• sterile-barrier-loss
• infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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