Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall
Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.
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: FDA Class II recall of a surgical implant inserter where potential separation of a critical mechanical component could impair device function during use. No injuries or illnesses reported; severity reflects the risk-of-harm nature of this surgical instrument.
Plain-English summary
Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter (Catalog 48019120, Lot 231638) distributed in the United States and Canada. The device is used to place spinal implants during surgical procedures.
The recall addresses a potential safety issue: the gold unlock button may separate from the inserter during use. If separation occurs, the inserter may not function properly, which could compromise the accuracy or safety of the surgical procedure.
Affected units were distributed to healthcare facilities in California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, Utah, and Canada. Facilities and healthcare providers in these areas should stop using the affected units immediately.
Users should contact Stryker Spine for instructions on device replacement or further guidance.
The recalled product
- Product
- Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
- Manufacturer
- Stryker Spine
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 48019120
- UDI-DI: 07613327500998
- Lot Number: 231638
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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