AutoTac Delivery Handle — Class II medical device recall Z-0561-2013
Terminated recall by BioHorizons Implant Systems Inc, reported 2012-12-26, distributed nationwide. The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
| Recall number | Z-0561-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioHorizons Implant Systems Inc, Birmingham, AL, United States |
| Recall initiated | 2012-11-19 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BG, BR, CA, CH, CL, CO, CR, DE, EC, EG, ES, FR, GB, GR, HK, ID, IL, IN, IR, IT, JO, JP, KR, KW, KY, LB, LT, MX, MY, PA, PE, PL, PT, RO, RS, SA, TH, TR, TW, UA, VN |
| Quantity | 174 units |
| Lot numbers | 02070051, 04070030, 06070018, 0800152, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, 1202282 |
| Model numbers | 400-200 |
Product
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Reason for recall
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
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-0561-2013. 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.