Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error
Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
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 structural defect in a medical device used during craniotomy, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,246 units of the Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp (Ref Number: 75-1040). The recall is due to a manufacturing defect where the Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
The affected devices are used for the re-attachment of the bone flap after a craniotomy. The recall covers units with an expiry date before 09/18/2023. The products were distributed worldwide, including in the United States, Canada, and numerous other countries.
Healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of them.
The recalled product
- Product
- Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,246
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 Expiry Date Before: 09/18/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer 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.
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