6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a seri...
FDA Device Recall #Z-1199-2017 — Class II — January 19, 2017
Recall Summary
| Recall Number | Z-1199-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 19, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Acumed LLC |
| Location | Hillsboro, OR |
| Product Type | Devices |
| Quantity | 15 units |
Product Description
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Reason for Recall
The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
Distribution Pattern
Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
Lot / Code Information
Lot number: 383813
Other Recalls from Acumed LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1218-2024 | Class II | Acu-Loc and Acu-Loc 2 bone plates, screws and a... | Dec 19, 2023 |
| Z-0618-2024 | Class II | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY,... | Nov 27, 2023 |
| Z-0770-2023 | Class II | Dual-Trak Clavicle Screws Part Number/Part Des... | Nov 29, 2022 |
| Z-0768-2023 | Class II | Acutrak 2 Part Number/Part Description: 30-00... | Nov 29, 2022 |
| Z-0769-2023 | Class II | AcuTwist Acutrak Compression Screws Part Numbe... | Nov 29, 2022 |
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.