External Implant RBT — Class II medical device recall Z-1058-2014
Terminated recall by BioHorizons Implant Systems Inc, reported 2014-02-26, distributed nationwide. The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in len
| Recall number | Z-1058-2014 |
|---|---|
| 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 | 2013-12-10 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-03-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, IN, KR, TW |
| Quantity | 119 units |
| Reason classes | labeling |
| Lot numbers | 1302762 |
| Model numbers | 40105D3 |
| Expiration dates | 2018-05-31 |
Product
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Reason for recall
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
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-1058-2014. 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.