Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk
Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.
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 where a functional defect (unthreading) poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver, a 3-piece orthopedic manual surgical instrument used to drive specific screws into the ilium. The recall is due to reports that surgeons have experienced unthreading of the screwdriver's outer shafts during use.
The affected units are identified by Catalog Number 48231326 and Lot Numbers 10G637, 10G638, and 10E852. These products were distributed nationwide, including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MO, MN, NC, NY, OH, OK, OR, PA, TN, TX, UT, and WI.
Healthcare facilities should stop using the affected devices and contact Stryker Spine for instructions on how to return or replace them.
The recalled product
- Product
- Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 46
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 (2)
- Catalog Number: 48231326. Lot Number: 10G637
- 10G638 and 10E852.
Distribution
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