TC-PLUS — Class II medical device recall Z-1544-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-04-27. The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being un
| Recall number | Z-1544-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-03-11 |
| Classified | 2016-04-21 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-04-10 |
| Countries outside the US | CH, DE |
| Quantity | 24 units |
| Lot numbers | B1500721, B1504644, B1508762 |
| Model numbers | 000, 017, 7500272 |
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Reason for recall
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.
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-1544-2016. 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.