Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
FDA Device Recall #Z-2126-2016 — Class II — November 25, 2015
Recall Summary
| Recall Number | Z-2126-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Anspach Effort, Inc. |
| Location | Palm Beach Gardens, FL |
| Product Type | Devices |
| Quantity | 20 hand pieces |
Product Description
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Reason for Recall
Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
Distribution Pattern
US Distribution to the state of : VA and Internationally to: Thailand and UK
Lot / Code Information
Part Number 530.710, Serial Numbers 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101077, 101078, 101079, 1011080, 101081, 101082, 101083, 101084, 101085
Other Recalls from The Anspach Effort, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0920-2023 | Class II | 7.5 cm Large Craniotome Attachment Use with XMa... | Dec 7, 2022 |
| Z-0922-2023 | Class II | 7.5 cm Large Rotating Craniotome Attachment. Us... | Dec 7, 2022 |
| Z-0918-2023 | Class II | Adult Craniotome Ref: CRANI-A-G1 Intended ... | Dec 7, 2022 |
| Z-0923-2023 | Class II | 6.5 cm Pediatric Craniotome Attachment. Use wit... | Dec 7, 2022 |
| Z-0924-2023 | Class II | Pediatric Craniotome Ref:CRANI-P-G1 | Dec 7, 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.