Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error
Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4).
Plain-English summary
Zimmer Biomet, Inc. is recalling 6,180 units of the Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, Reference Number 75-1040-12. The recall affects lots with an expiry date before 09/18/2023. The product is a medical device used for the re-attachment of the bone flap after a craniotomy.
The recall was initiated because the Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including the United States, Canada, and numerous international markets such as Argentina, Australia, Belgium, Brazil, and others. Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 6,180
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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