SmartTools Knee System Orthopedic Stereotaxic Instrument — Class II medical device recall Z-1868-2017
Terminated recall by Orthosoft, Inc. dba Zimmer CAS, reported 2017-04-26, distributed nationwide. There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation T
| Recall number | Z-1868-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS, Montreal, N/A, Canada |
| Recall initiated | 2017-02-20 |
| Classified | 2017-04-19 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 84 |
| Lot numbers | 130542A1, 140146, 140146-1, 140147, 140407-B-1, 140407A, 140407A-1, 140407B, 1405941, 140860, 140860-1, 141035, 150120, B150120, B150711 |
Product
SmartTools Knee System Orthopedic Stereotaxic Instrument
Reason for recall
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
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-1868-2017. 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.