Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips — Class II medical device recall Z-0718-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-01-22, distributed nationwide. Recall was initiated due to the observation of separation between clear layers of the pouch during real time a
| Recall number | Z-0718-2014 |
|---|---|
| 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 | 2011-09-09 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2016-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DO, EC, EG, ES, FI, FR, GB, GR, HK, HN, IL, IN, IS, IT, JM, JO, JP, KE, KR, KY, LT, MX, MY, NG, PA, PH, PT, SE, SG, TR, TW, ZA |
| Reason classes | sterility |
| Lot numbers | 0323037765, 0453041480, 5-150, 5JL-3-10, 612852, 612853, 612854, 8043003078, C023015915, C233022345, C403026574, COA-1R, MA15-8N, MA1S-8N, S-150 |
| Model numbers | 0.011-40, 0011-158, 0011-5, 0011-50V, 0011-50X, 0011-56, 0011-58, 0011-59, 0011-620RM, 0011-62DRM, 0011-LR, 0011-SB, 0014-350, 0014-40, 0014-48, 0014-58, 0023027306, 0023030312, 0023030457, 0023030690, 0023030704, 0023030717, 0023030737, 0033030268, 0033030574 and 475 more |
Product
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Reason for recall
Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.
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-0718-2014. 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.