Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty
Biomet Microfixation is recalling 5 Thinflap System 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, and the hazard involves a mechanical defect requiring excessive force, which poses a risk of injury but is not a Class I defect or associated with reported fatalities.
Plain-English summary
Biomet Microfixation, LLC is recalling 5 units of the Thinflap System Case, model number 19-5000, lot code 101465. 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 product numbers 17-5000 and 19-5000 could not be opened by the user without the application of undesirable or unexpected excessive force.
The affected units were distributed nationwide, including in California, Florida, Oklahoma, New York, North Carolina, and Illinois. Users should stop using the affected cases and contact Biomet Microfixation for instructions on return or replacement.
The recalled product
- Product
- Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
- Manufacturer
- Biomet Microfixation, LLC
- Affected units
- 5
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 # 101465 Model # 19-5000
Distribution
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.
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