Exactech 1 — Class II medical device recall Z-2644-2017
Terminated recall by Exactech, Inc., reported 2017-07-05, distributed nationwide. The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique a
| Recall number | Z-2644-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-05-22 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CH, CN, CO, DE, ES, FR, GB, GT, IN, IT, JP, TR |
| Quantity | 477 |
| Reason classes | labeling, device malfunction |
| Lot numbers | 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-005, 52224-006, 52224-007, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 74999-001, 75153-001 |
| Model numbers | 161-30-00 |
Product
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
Reason for recall
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
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-2644-2017. 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.