Titanium Tack Starter Kit — Class II medical device recall Z-0562-2013
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-0562-2013 |
|---|---|
| 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 | 1,246 units |
| Lot numbers | 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, 1203107, K0207015, K0208005, K0208005R, K0307007 and 21 more |
| Model numbers | 400-270 |
Product
Titanium Tack Starter Kit, REF 400-270, 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-0562-2013. 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.