Verasense Knee System — Class II medical device recall Z-1029-2015
Terminated recall by Orthosensor, Inc., reported 2015-02-04, distributed in CA, IL, MI, NV, NY, VA. Presence of one inoperable (dead) sensor pad.
| Recall number | Z-1029-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosensor, Inc., Sunrise, FL, United States |
| Recall initiated | 2014-12-05 |
| Classified | 2015-01-29 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-03-13 |
| Distributed | CA, IL, MI, NV, NY, VA |
| Quantity | 22 devices |
| Lot numbers | 091914V11770 |
| Serial numbers | 411585003, 411585005, 411585007, 411585011, 411585014, 411585017, 411585023, 411585030, 411585032, 411585035, 411585036, 411654001, 411654004, 411654005, 411654007, 411654008, 411654010, 411654011, 411654012, 411654014, 411654015, 411654016, 411654018, 411654020 |
Product
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Reason for recall
Presence of one inoperable (dead) sensor pad.
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-1029-2015. 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.