Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error
Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.
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. Per the rubric, risk-of-harm products where injury has not yet been reported fall under the High severity category.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Biomet Microfixation RapidFlap System, specifically the 12MM RapidFlap SpinDown Clamp (Ref Number: 75-1020-12). The recall involves 11,736 units that were distributed worldwide, including the United States, Canada, and numerous international markets. The product is 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. 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, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected clamps and contact Zimmer Biomet for further instructions. Patients who have had these devices implanted should consult their healthcare provider regarding the recall.
The recalled product
- Product
- Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 11,736
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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