Data Foundry

Medical device recalls 2015

Drill set long — Class II medical device recall Z-0981-2015

Terminated recall by Straumann USA, LLC, reported 2015-01-21, distributed nationwide. Drill set may contain incorrect drill.

Recall numberZ-0981-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStraumann USA, LLC, Andover, MA, United States
Recall initiated2014-10-27
Classified2015-01-15
Reported by FDA2015-01-21
Terminated2015-04-10
DistributedNationwide (US)
Countries outside the USAT, AU, BE, CA, CH, DE, ES, FI, FR, GB, IE, IT, NL
Quantity362 units
Lot numbersGY037, HA443, HE874, HL216

Product

Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

Reason for recall

Drill set may contain incorrect drill.

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-0981-2015. 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.