Recall Z-1545-2016
Smith & Nephew, Inc. · initiated March 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Codes / lots: Batch numbers: B1510531, B1506602, B1502407
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.
FDA-determined cause: Process control
Action taken
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock. If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
Details
- Recall number
- Z-1545-2016
- Initiated
- March 11, 2016
- Posted by FDA
- April 21, 2016
- Terminated
- April 10, 2017
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 22 units
- Distribution
- International Distribution only in countries of: Germany and Switzerland.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1537-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1538-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1539-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1540-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1541-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1542-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1543-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1544-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1546-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1547-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1548-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1549-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1550-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1551-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |