Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non steril...
FDA Device Recall #Z-2054-2012 — Class II — May 31, 2012
Recall Summary
| Recall Number | Z-2054-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 31, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes (USA) Products LLC |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 12 units |
Product Description
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
Reason for Recall
USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).
Distribution Pattern
Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
Lot / Code Information
Catalog number 498.321, lot/serial #6876785
Other Recalls from Synthes (USA) Products LLC
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| Z-0228-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM... | Sep 26, 2025 |
| Z-0229-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM... | Sep 26, 2025 |
| Z-1916-2024 | Class II | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/... | Apr 25, 2024 |
| Z-1239-2024 | Class II | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... | Jan 24, 2024 |
| Z-1238-2024 | Class II | RAPIDSORB IPS Battery Pack, Sterile-Intended fo... | Jan 24, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.