Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Reported: April 9, 2025 Initiated: February 28, 2025 #Z-1488-2025
Product Description
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Reason for Recall
Potential for the gold unlock button to separate from the inserter.
Details
- Recalling Firm
- Stryker Spine
- Units Affected
- 64 units (60 US, 4 OUS)
- Distribution
- Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.. Recalled by Stryker Spine. Units affected: 64 units (60 US, 4 OUS).
Why was this product recalled? ▼
Potential for the gold unlock button to separate from the inserter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1488-2025.
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