Orthosize Templating Version 1 — Class II medical device recall Z-1495-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-03-29, distributed nationwide. Digital templates were created with the incorrect files.
| Recall number | Z-1495-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-02-14 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CN, DE, DK, ES, FI, FR, GB, GR, IN, IT, JP, KR, LT, MX, MY, NI, NL, NO, PK, PL, PT, RO, SE, SG, TR, ZA |
| Quantity | 3,232 |
Product
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Reason for recall
Digital templates were created with the incorrect files.
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-1495-2017. 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.