Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error
Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.
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 involves a structural defect in a medical device used for craniotomy, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 12,825 units of the Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile (Ref Number: 75-1020). The recall is due to a manufacturing defect where the Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. This device is used for the re-attachment of the bone flap after a craniotomy.
The affected units were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, South America, and Africa. The recall applies to lots with an expiry date before 09/18/2023.
Healthcare facilities and distributors should stop using the affected clamps and contact Zimmer Biomet for instructions on return or replacement. Patients who have already received the device should consult their healthcare provider regarding the potential impact of the assembly error.
The recalled product
- Product
- Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12,825
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · assembly error
See all →- ModerateKnee fusion nail components recalled over a locking screw inserted backwards
FDA (Food) · 2025-12-17
- HighMiniaturized TEE probes recalled over reversed articulation from assembly error
FDA (Devices) · 2025-10-15
- ModeratePhasor neurosurgical drills may have a reverse battery orientation
FDA (Devices) · 2025-08-06
- SevereMedline Fluid Delivery Sets incorrectly assembled with wrong drip chamber
FDA (Devices) · 2025-01-22
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03