Tapered HD Upgrade Set — Class II medical device recall Z-1605-2015
Terminated recall by BioHorizons Implant Systems Inc, reported 2015-05-20, distributed nationwide. BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless st
| Recall number | Z-1605-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioHorizons Implant Systems Inc, Hoover, AL, United States |
| Recall initiated | 2015-04-16 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 48 units |
| Lot numbers | 1501968 |
Product
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Reason for recall
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
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-1605-2015. 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.