Product Catalog — Class II medical device recall Z-0200-2014
Terminated recall by The Anspach Effort, Inc., reported 2013-11-20, distributed nationwide. Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneu
| Recall number | Z-0200-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2011-05-06 |
| Classified | 2013-11-12 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2016-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HU, IL, IN, IT, JM, JO, JP, KR, KY, LB, LT, MX, MY, NG, NL, NO, PA, PE, PT, SA, SE, SG, TH, TR, TW, VE, ZA |
| Quantity | 2,020 |
| Reason classes | labeling |
| Model numbers | 20-0020 |
Product
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
Reason for recall
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0200-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.