LITe Decompression Snake Arm, REF 48080230
- Company
- Stryker Spine
- Recall Initiated
- November 1, 2023
- Posted
- December 21, 2023
- Recall Number
- Z-0610-2024
- Quantity
- 9
- Firm Location
- Allendale, NJ
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.
Distribution
US: MD, MI, NM, TX & OUS: Canada & France.
Lot / Code Info
UDI-DI (GTIN): 07613327263909, lot # 227764.
Root Cause
Nonconforming Material/Component
Action Taken
Stryker issued Urgent Medical Device Correction on 11/20/2023 notifying customers of removal of lot 227764 of the LITe Decompression Tube Snake Arm, catalog number 48080230. A portion of one lot of the LITe Decompression Tube Snake Arm was manufactured with the incorrect clamp component. As a result, the affected Snake Arms cannot attach to the arm post shaft. Customers are to review inventory and remove units from points of use for return to Stryker, share this information with appropriate personnel and return the Business Reply form to Spine-RegulatoryActions@Stryker.com. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.