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.
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: 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
- Hazard
- mechanical-failure
- 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 48019120
- UDI-DI: 07613327500998
- Lot Number: 231638
Distribution
Distributed in 13 states:
- CA
- CO
- FL
- GA
- IL
- MA
- NE
- NH
- NY
- OK
- PA
- TX
- UT
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