Zimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect
Zimmer Biomet is recalling the Virage OCT Spinal Fixation System because set screw staking is out of specification, which can interfere with rod insertion.
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 high-risk medical device where a mechanical defect can interfere with the insertion of a spinal rod. No injuries or illnesses are reported in the source text, placing this in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Virage OCT Spinal Fixation System, Item Number 07.01738.001. This posterior system is intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). The recall involves 372 units distributed across 20 U.S. states and four countries: Australia, Germany, Switzerland, and Sweden.
The recall was initiated after product testing revealed that the staking of the set screw was out of specification. This defect can interfere with the insertion of the occipital rod when the set screw is staked too low. The affected lot numbers are 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, and 62874869.
Healthcare providers and facilities should contact Zimmer Biomet to determine if they have affected units and to arrange for the appropriate corrective action.
The recalled product
- Product
- Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Spinal Fixation
- Affected units
- 372
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 (7)
- Lots: 62968065
- 62947660
- 62536230
- 62745662
- 62773482
- 62758613
- 62874869
Distribution
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