KYNClass IIIImplant
Prosthesis, Wrist, Constrained, Metal
Orthopedic · 21 CFR 888.3790
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- UROPASS AS 11/13FR X 38 CM 5/BXApr 14, 2021MalfunctionTeleflex Medical Oem3003790304-2021-00067
- UNKNOWN DVR PLATEDec 14, 2020InjuryZimmer Biomet, Inc.0001825034-2020-04352
- UROPASS AS 12/14FR X 54 CM 5/BXJul 15, 2019MalfunctionTeleflex Medical Oem2951238-2019-01008
- UROPASS AS 12/14FR X 54 CM 5/BXJul 15, 2019MalfunctionTeleflex Medical Oem2951238-2019-01009
- UROPASS AS 10/12FR X 38 CM 5/BXMay 29, 2018MalfunctionTeleflex Medical Oem3005975494-2018-00007
- UROPASS AS 12/14FR X 54 CM 5/BXJul 10, 2017MalfunctionTeleflex Medical Oem2951238-2017-00445
Event type breakdown
Malfunction5
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.