Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture
Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.
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 medical device that fractured during surgery, representing a risk-of-harm product where injury has not yet been explicitly reported in the source text.
Plain-English summary
Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench, Catalog number IS3002XLP, Lot number 4279. The non-sterile device is used to final tighten specific spinal components to 12 Nm.
The recall was initiated after Stryker received a customer complaint regarding a fracture of the wrench during use in surgery. The affected units were distributed to Georgia, Indiana, Michigan, New Jersey, Ohio, Pennsylvania, Texas, and Virginia.
Healthcare facilities should stop using the affected units and contact Stryker Spine for further instructions.
The recalled product
- Product
- Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 15
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 number 4279
Distribution
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