Impactor
Orthopedic · 21 CFR 888.4540
Recent MDR events
19,287 adverse event reports on file
- FM HEAD REPL PLAS TIPJul 31, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-01044
- PINNACLEJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13082
- EMPHASYSJul 31, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-13091
- SELF CENTERINGJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13113
- EMPHASYSJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12969
- SIGMAJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12973
- SELF CENTERINGJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12975
- ATTUNEJul 30, 2026MalfunctionDepuy Ireland - 96166711818910-2026-12991
- DPS HD IMP TIPJul 30, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-13001
- EMSYS LNR IMP TIP 36Jul 30, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-13024
Event type breakdown
Recalls
27 recall events for this product code
- Exactech, Inc.Open, ClassifiedMar 9, 2026
Brand Name: Equinoxe Ergo
Impactor handle may be missing cross-pin
Z-1509-2026 · View FDA record ↗ - Exactech, Inc.Open, ClassifiedMar 9, 2026
Brand Name: Equinoxe
Impactor handle may be missing cross-pin
Z-1510-2026 · View FDA record ↗ - INCIPIO DEVICESOpen, ClassifiedNov 25, 2024
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Z-0549-2025 · View FDA record ↗ - Exactech, Inc.Open, ClassifiedJun 30, 2023
Exactech Ergo Impactor Handle, Catalog #321-09-05.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Z-2051-2023 · View FDA record ↗ - Enztec LimitedTerminatedJan 24, 2020
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
Z-0612-2020 · View FDA record ↗ - Exactech, Inc.TerminatedSep 10, 2019
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Z-2499-2019 · View FDA record ↗ - Greatbatch MedicalTerminatedNov 29, 2016
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #:
On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).
Z-0367-2017 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedOct 7, 2016
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stry
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Z-0060-2017 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 24, 2014
Trabecular Metal Tibial Impactor.
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
Z-0423-2015 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 24, 2014
Trabecular Metal Tibial Impactor Replacement Pads.
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
Z-0424-2015 · View FDA record ↗
Registered firms
306 firms currently registered for this product code
B-one Medical (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Seaspine Orthopedics Corporation
Carlsbad, CA, US
Eptam Plastics, Ltd
Northfield, NH, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Bradford Tool Group
Bradford York, GB
Ortho-med, Inc.
Tigard, OR, US
Elite Medical, Llc
Bartlett, TN, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Aesculap Sas
CHAUMONT Grand Est, FR
Johnson & Johnson Medical (depuy - Suzhou) Ltd.
SUZHOU Jiangsu, CN
Alphatec Spine, Inc.
Memphis, TN, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Xtant Medical Holdings, Inc.
Belgrade, MT, US
Shanghai Reach Medical Instrument Co., Ltd
Shanghai, CN
Lincotek Medical Llc
Vandalia, OH, US
Trimed, Inc.
Santa Clarita, CA, US
A.handte Medizintechnik Gmbh & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Uoc Usa Inc.
Irvine, CA, US
Gs Medical Co., Ltd.
Heungdeok-gu, Cheongju-si Chungbuk, KR
B & J Medical Llc
Kendallville, IN, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Rsb Spine Llc.
Wooster, OH, US
Jabil Inc. (brandywine)
W Chester, PA, US
Aap Implantate Ag
BERLIN, DE