Recall Z-0610-2024— Stryker Spine
Class II · Ongoing
Class II FDA medical device recall by Stryker Spine, initiated 2023-11-01. FDA's recall record names no specific 510(k) clearance for this event. Product: LITe Decompression Snake Arm, REF 48080230. Reason: Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-01
- Firm location
- Allendale, NJ, United States
Product description
LITe Decompression Snake Arm, REF 48080230
Reason for recall
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Data sourced from openFDA. This site is unofficial and independent of the FDA.