Countersink
Orthopedic · 21 CFR 888.4540
Recent MDR events
15 adverse event reports on file
- CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AOApr 26, 2018MalfunctionZimmer Gmbh0009613350-2018-00484
- CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AODec 15, 2017MalfunctionZimmer Gmbh0009613350-2017-01773
- CBS CSK15MM AO CAN1.4MM DPCBS4Oct 19, 2017MalfunctionZimmer Gmbh0009613350-2017-01480
- WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AOMar 21, 2017InjuryZimmer Gmbh0009613350-2017-00417
- WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AOMar 21, 2017InjuryZimmer Gmbh0009613350-2017-00418
- WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AOSep 20, 2016InjuryZimmer Gmbh0009613350-2016-01209
- COUNTERSINKAug 15, 2016InjurySynthes Usa2520274-2016-14101
- COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5Dec 28, 2015MalfunctionStryker Gmbh0008031020-2015-00676
- COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5Oct 16, 2015MalfunctionStryker Gmbh0008031020-2015-00411
- COUNTERSINK FOR 3.5MM CORTEX AND 4.0MM CANC BONE SCREWSMay 24, 2013MalfunctionSynthes Gmbh8030965-2013-02359
Event type breakdown
Most-reported manufacturers
Recalls
17 recall events for this product code
- Aesculap Implant Systems LLCTerminatedJul 3, 2012
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision s
Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Z-1934-2012 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1454-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1455-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1456-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1457-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1458-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1459-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS micro, countersink, cannulated, AO, Item Number 503004541
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1460-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
CBS high, countersink, cannulated, AO, Item Number 503004542
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1461-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Z-1462-2019 · View FDA record ↗
Registered firms
114 firms currently registered for this product code
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
Pacific Instruments Inc.
Honolulu, HI, US
Trimed, Inc.
Santa Clarita, CA, US
Ortho Cape
Montauban Tarn-et-Garonne, FR
Teleflex Llc (nadc)
Olive Branch, MS, US
Holmed Llc
Attleboro, MA, US
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Autocam Medical
Kentwood, MI, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Highridge Medical, Llc
Westminster, CO, US
Glw, Inc.
Englewood Cliffs, NJ, US
Aap Implantate Ag
BERLIN, DE
Princeton Medical Group, Inc.
Franklin, TN, US
Avalign Instruments & Implants
FORT WAYNE, IN, US
3d Instrumentation Sdn Bhd
Bukit Mertajam Pulau Pinang, MY
Med Saver, Inc.
PHOENIXVILLE, PA, US
Synthes Gmbh
Zuchwil Solothurn, CH
Wright Medical Technology, Inc.
Arlington, TN, US
Gpc Medical Limited
Ghaziabad Uttar Pradesh, IN
Tyber Medical
Bethlehem, PA, US
In'tech Medical Sas
RANG DU FLIERS Pas-de-Calais, FR
Autocam Medical
Murfreesboro, TN, US
Gramercy Extremity Orthopedics, Llc.
Richardson, TX, US
Merete Gmbh
BERLIN, DE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.