The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0136-2016·Announced 2015-10-28

Biomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled

Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity issue involving a functional defect rather than a direct health hazard.

Plain-English summary

Biomet Microfixation, LLC is recalling 37 Neuro Combo Set Cases, Model # 17-5000, Lot Code # 101337. These cases are designed to hold surgical instrumentation in place during handling and storage.

The recall was initiated because the lids on the implant caddies within the affected product numbers could not be opened by the user without the application of undesirable or unexpected excessive force. The agency has classified this recall as Class II.

The affected products were distributed nationwide, including in California, Florida, Oklahoma, New York, North Carolina, and Illinois. Users should contact Biomet Microfixation, LLC for further instructions regarding the recall.

The recalled product

Product
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Manufacturer
Biomet Microfixation, LLC
Category
Medical Device — Surgical Instrumentation Case
Hazard
Affected units
37

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 Code # 101337 Model # 17-5000

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Biomet Microfixation, LLC 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 2 products in this recall →

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