Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error
Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are 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 FDA classified this as a Class II recall. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Zimmer Biomet, Inc. is recalling 11,580 units of the Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, Reference Number 75-1030-12. These medical devices are used for the re-attachment of the bone flap after a craniotomy. 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 products have a lot expiry date before 09/18/2023. The devices were distributed worldwide, including in the United States, Canada, and numerous international locations such as Argentina, Australia, Belgium, Brazil, and the United Kingdom.
Healthcare providers and facilities should stop using the affected clamps and contact Zimmer Biomet for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 11,580
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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