Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error
Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
What this means for you
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 is classified as FDA Class II, which the rubric associates with significant injury or property damage reports or high-risk scenarios. As no specific injuries are reported in the text, it falls under the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 23,726 units of the Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp (Ref Number: 75-1030). 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. Distribution was worldwide, including the United States, Canada, and numerous international locations.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the affected devices.
The recalled product
- Product
- Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 23,726
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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