The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0629-2021·Announced 2020-12-23

Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates

Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.

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: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, which corresponds to a High severity score of 3 per the rubric.

Plain-English summary

Biomet, Inc. is recalling specific lots of the Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12. This medical device is used for the fixation of cranial bone. The recall involves 7,428 units from Lot 078390.

The recall was initiated because specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device.

The affected products were distributed worldwide, including in the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.

The recalled product

Product
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Neurosurgical
Hazard
Affected units
7,428

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 (1)

  • Lot 078390

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

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