The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0812-2022·Announced 2022-03-30

Biomet Trauma Surgical Instruments Recalled Due to Packaging Defect

Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II medical device recall for surgical instruments with a packaging defect that compromises sterile barrier integrity, creating risk of infection. No illnesses or injuries are reported in the source, which per the rubric places this in the 'risk-of-harm products where injury has not yet been reported' category.

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…
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,594

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 (20)

  • 44 lots: Lot #
  • UDI # - [014490
  • (01)00887868447037(17)310608(10)014490]
  • [014500
  • (01)00887868447068(17)310608(10)014500]
  • [014520
  • (01)00887868447068(17)310610(10)014520]
  • [084850
  • (01)00887868447006(17)310621(10)084850]
  • [084860
  • (01)00887868447006(17)310623(10)084860]
  • [084870
  • (01)00887868447006(17)310623(10)084870]
  • [084880
  • (01)00887868447006(17)310624(10)084880]
  • [102920
  • (01)00887868447006(17)310630(10)102920]
  • [102930
  • (01)00887868447006(17)310716(10)102930]
  • [102940

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 4 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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