Driver, Prosthesis
Orthopedic · 21 CFR 888.4540
Recent MDR events
9,682 adverse event reports on file
- ATTUNEJul 31, 2026MalfunctionDepuy Ireland - 96166711818910-2026-13074
- CUP INTRODUCER 26/28MMJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13081
- SYMPHONYJul 30, 2026MalfunctionDepuy Spine Inc1526439-2026-01118
- SYMPHONYJul 30, 2026MalfunctionDepuy Spine Inc1526439-2026-01119
- SYMPHONYJul 30, 2026MalfunctionDepuy Spine Inc1526439-2026-01120
- ANGLED ACET INSERTRJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12967
- SKYLINE SPRING CLIP DRIVERJul 30, 2026MalfunctionDepuy Spine Inc1526439-2026-01121
- SKYLINEJul 30, 2026MalfunctionDepuy Spine Inc1526439-2026-01122
- RECLAIM PRONGED STEM STBLZRJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12995
- INHANCEJul 30, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-12999
Event type breakdown
Recalls
6 recall events for this product code
- Smith & Nephew, Inc., Endoscopy Div.TerminatedJan 29, 2016
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Z-0699-2016 · View FDA record ↗ - Biomet Microfixation, Inc.TerminatedApr 11, 2010
BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT.
The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.
Z-1319-2010 · View FDA record ↗ - Wright Medical Technology IncTerminatedNov 27, 2007
Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Breakage: breaking of the connecting foot that is on the distal surface of the instrument
Z-0290-2008 · View FDA record ↗ - Pioneer Surgical TechnologyTerminatedNov 27, 2007
Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
Z-0291-2008 · View FDA record ↗ - Biomet U.K., Ltd.TerminatedUnknown
Oxford Unicompartmental Knee Phase 3 Tibial Impactor
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Z-1154-2017 · View FDA record ↗ - Biomet U.K., Ltd.TerminatedUnknown
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Z-1155-2017 · View FDA record ↗
Registered firms
179 firms currently registered for this product code
United Orthopedic Corp.
Kaohsiung, TW
Smith & Nephew Inc.
ANDOVER, MA, US
Alpes Cn Sas
Reignier-Esery Haute-Savoie, FR
Clariance-sas
BEAURAINS Hauts-de-France, FR
Diamond Orthopedic
Gastonia, NC, US
Encore Medical, L.p.
AUSTIN, TX, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Nuvasive, Inc.
SAN DIEGO, CA, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
C+a Tool Engineering, Inc.
Churubusco, IN, US
Synthes (usa) Products Llc
West Chester, PA, US
Signature Orthopaedics Pty Limited
Sydney New South Wales, AU
In2bones Usa, Llc
Cordova, TN, US
Biomet Uk Ltd.
BRIDGEND, GB
Foundation Fusion Solutions, Llc
Tulsa, OK, US
Arch Medical Solutions - Seabrook
SEABROOK, NH, US
Autocam Medical
Murfreesboro, TN, US
Kalitec Direct Llc Dba Kalitec Medical
Sarasota, FL, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Riverside Machine & Engineering, Inc.
Eau Claire, WI, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Smith & Nephew Inc.
MANSFIELD, MA, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Lisi Medical Remmele
Big Lake, MN, US
In'tech Medical Sas
RANG DU FLIERS Pas-de-Calais, FR
510(k) clearances
4 clearances for this product code