Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture
Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.
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 is classified as FDA Class II. The hazard involves a mechanical failure (fracture) of a surgical instrument during use, which presents a risk of harm to patients or providers, but the source text does not report specific injuries or hospitalizations, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Spine is recalling 54 units of the XIA 3 Torque Wrench (Catalog Number 48237028) due to reports of the hex tip fracturing during final tightening. The affected units are from lot numbers 093653, 093654, and 093655. The device is a Class II medical device used to tighten specific spinal fixation components.
The recall was initiated after multiple complaints indicated that the hex tip of the torque wrench fractured while the instrument was being used to apply torque. The product was distributed nationwide in the United States and internationally to Australia, Canada, France, Germany, the Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Healthcare providers and facilities that have received these devices should stop using them immediately and contact Stryker Spine for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 54
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 (4)
- Class I device
- 510(K) exempt Catalog Number: 48237028 Lot Number: 093653
- 093654
- 093655
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Spine 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.
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