.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use wi...
FDA Device Recall #Z-2077-2012 — Class II — September 19, 2011
Recall Summary
| Recall Number | Z-2077-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 19, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Anspach Effort, Inc. |
| Location | Palm Beach Gardens, FL |
| Product Type | Devices |
| Quantity | 5 each |
Product Description
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Reason for Recall
Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
Distribution Pattern
US Nationwide Distribution including the states of: Arizona. and California.
Lot / Code Information
Lot numbers E203050779 and E383055709.
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
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.