Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk
Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of implant fracture, which constitutes a significant injury risk under the severity rubric.
Plain-English summary
Atlas Spine, Inc. is recalling 16 units of the Atlas Spine Torque Limiting Handle 6N-m (P/N 70089, Model # ITN-001-000). The device is used to rotate implants into position. The recall covers lots 8887, 000073, 000135, 00434, and 02518.
The recall was initiated because the device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. The FDA has classified this as a Class II recall.
The affected units were distributed nationwide to Florida, Missouri, and West Virginia. No specific instructions for consumers are provided in the source text, but the recall is managed by Atlas Spine, Inc.
The recalled product
- Product
- Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Manufacturer
- Atlas Spine, Inc.
- Hazard
- Affected units
- 16
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 (5)
- Lots #: 8887
- 000073
- 000135
- 00434
- and 02518.
Distribution
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