Stryker Monterey AL Implant Inserter Gold Button Detachment Risk
Stryker Spine is recalling Monterey AL Implant Inserters due to a potential defect where the gold unlock button may separate from the device, compromising its function during spinal surgery.
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 a Class II FDA medical device recall for a surgical implant inserter with a potential mechanical defect. No deaths, injuries, or illnesses have been reported. The hazard—button separation—represents a risk of harm to patients during spinal procedures, meeting the criterion for High severity.
Plain-English summary
Stryker Spine is recalling the Monterey AL Implant Inserter (10/12mm, Catalog 48019100) due to a potential manufacturing defect. The gold unlock button on the inserter may separate from the device.
This recall affects 64 units: 60 distributed in the United States across California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, and Utah; and 4 units distributed in Canada. The affected lot number is 231634.
Healthcare providers and patients who have received this device should contact Stryker Spine immediately. Do not use the device if any separation of the button is observed or suspected.
The recalled product
- Product
- Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
- Manufacturer
- Stryker Spine
- Category
- Medical Device — Spinal Implants
- Hazard
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 48019100
- UDI-DI: 07613327456462
- Lot Number: 231634
Distribution
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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