Smith & Nephew, Inc. Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4
Smith & Nephew, Inc. Recall: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Smith & Nephew, Inc.; Product: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Ne
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | International Distribution only in countries of: Germany and Switzerland. |
| Recall initiated | 20160311 |
| Recall number | Z-1544-2016 |
| Category | device |
| State | TN |
| Country | United States |
$29/mo
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