Zimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System
Zimmer Biomet is recalling 141 units of the Altius M-INI OCT Posterior Spinal Fixation System because the driver cannot mate with the screw head tulip.
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 recall involves a high-risk medical device (spinal fixation system) where a mechanical defect could lead to injury, but the source text does not report any specific illnesses or injuries, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Zimmer Biomet Spine, Inc. is recalling 141 units of the Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216. The recall is due to a defect where the driver is unable to mate with the screw head tulip.
The affected products are indicated for promoting fusion of the cervical spine and occipitocervico-thoracic junction. The distribution pattern includes the United States (nationwide) and the Netherlands. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to manage the affected devices. The source text does not provide specific consumer action steps beyond the standard recall notification.
The recalled product
- Product
- Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain…
- Manufacturer
- Zimmer Biomet Spine, Inc
- Hazard
- Affected units
- 141
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 (14)
- 505951
- M16562R01
- 510710
- 510981
- 514814
- 533566
- 536398
- 543663
- 546565
- 546566
- 549528
- 565465
- 565464
- 567525
Distribution
Distributed nationwide across the United States.
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