Stryker Spine Monterey AL Implant Inserter Recall Due to Potential Gold Button Separation
Stryker Spine is recalling the Monterey AL Implant Inserter because the gold unlock button may separate from the device, which could affect functionality during surgical procedures.
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: This is an FDA Class II recall involving a potential component defect in a surgical device that could affect device functionality. The hazard constitutes a risk-of-harm product, but no illnesses or injuries have been reported. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Stryker Spine is recalling the Monterey AL Implant Inserter (Catalog 48019130) due to a potential defect in which the gold unlock button may separate from the inserter. This component separation could compromise the device's intended functionality.
46 units have been affected (44 in the United States and 2 internationally). The devices were distributed to facilities in California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, and Utah, as well as Canada. The affected product has Lot Number 231639 and UDI-DI 07613327501049.
Healthcare providers should stop using the affected devices immediately. Stryker Spine recommends contacting the company for return instructions and information about replacement devices. No illnesses or injuries have been reported related to this defect.
The recalled product
- Product
- Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
- Manufacturer
- Stryker Spine
- Category
- Medical Device — Spinal Implant
- Hazard
- component-separation
- device-malfunction
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 (3)
- Catalog 48019130
- UDI-DI: 07613327501049
- Lot Number: 231639
Distribution
Distributed in 13 states:
- CA
- CO
- FL
- GA
- IL
- MA
- NE
- NH
- NY
- OK
- PA
- TX
- UT
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