Recall Z-0610-2024 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
LITe Decompression Snake Arm, REF 48080230
| Date | Dec 21, 2023 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| Reason | Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft. |
| Root cause | Nonconforming Material/Component |
| Action | 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 qu |
| Quantity | 9 |
| Distribution | US: MD, MI, NM, TX & OUS: Canada & France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.