Device product
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Z-1509-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67972
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,072 ea.
- Official record key
device-enforcement:Z-1509-2014
Official wording
Reason: Product does not meet minimum knot tensile strength requirements.
Code information: Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
Distribution pattern: Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Derived failure modes
-
Unknown
Product does not meet minimum knot tensile strength requirements.