Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Orthopedic · 21 CFR 888.3030
Recent MDR events
9,903 adverse event reports on file
- UNK - Constructs: 2.7-/3.5-mm VA-LCP Olecranon Plate and ScrewsJul 28, 2026InjurySynthes Gmbh8030965-2026-07765
- CABLE READY GTR COCR CABLEJul 27, 2026DeathZimmer Biomet, Inc.0001822565-2026-02676
- MAXFRAME AUTOSTRUT(TM)HEXAPOD CTRL KITJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07654
- LCP OlecranonJul 27, 2026InjurySynthes Gmbh8030965-2026-07733
- Monkey Rings HALF PIN SLF DRLG 5.0X45MMJul 27, 2026InjuryParagon 283008650117-2026-00440
- INSERT FOR FNS INSERTION HANDLEJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07756
- HOFFMANN II CONNECTING ROD MICRO D3 X 40MMJul 20, 2026MalfunctionStryker Gmbh0008031020-2026-00882
- HOFFMANN II CONNECTING ROD MICRO D3 X 30MMJul 20, 2026MalfunctionStryker Gmbh0008031020-2026-00881
- HOFFMANN II CONNECTING ROD MICRO D3 X 50MMJul 20, 2026MalfunctionStryker Gmbh0008031020-2026-00883
- HOFFMANN II CONNECTING ROD MICRO D3 X 60MMJul 20, 2026MalfunctionStryker Gmbh0008031020-2026-00884
Event type breakdown
Recalls
89 recall events for this product code
- Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2827-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2828-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2829-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2830-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2831-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2832-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedJul 29, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2833-2026 · View FDA record ↗ - Orthofix U.S. LLCOpen, ClassifiedJul 14, 2026
Orthofix MINIRAIL, STANDARD LENGTHENER
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2729-2026 · View FDA record ↗ - Orthofix U.S. LLCOpen, ClassifiedJul 14, 2026
Orthofix MINIRAIL, SHORT, LENGTHENER
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2730-2026 · View FDA record ↗ - Orthofix U.S. LLCOpen, ClassifiedJul 14, 2026
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2731-2026 · View FDA record ↗
Registered firms
1,471 firms currently registered for this product code
Hn And M Gmbh
Derendingen Solothurn, CH
Sterigenics U.s., Llc
Santa Teresa, NM, US
Synthes (usa) Products Llc
West Chester, PA, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Arthrex, Inc.
Naples, FL, US
Sterigenics U.s. Llc
MULBERRY, FL, US
Anthogyr
SALLANCHES Haute-Savoie, FR
Avalign Delivery Systems Division
Greenwood, IN, US
Quintus, Inc.
Camp Verde, AZ, US
Zimmer Pte. Ltd.
Singapore South East, SG
Microware Precision Co., Ltd.
Taichung, TW
Depuy Synthes Sales
Bridgewater, MA, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Sterigenics Us Llc
West Memphis, AR, US
Biomet, Inc.
WARSAW, IN, US
Viant Medical, Llc
Fort Wayne, IN, US
Jabil Inc. (elmira)
Horseheads, NY, US
Lx Precision Shanghai Co Ltd
Shanghai, CN
Stryker Gmbh
SELZACH Solothurn, CH
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
510(k) clearances
404 clearances for this product code
- Synthes (USA) Products, LLCJun 11, 2026
K254087 · MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- Vilex, LLCApr 17, 2026
K260900 · DYNEX® External Fixation Systems
- Stabiliz Orthopaedics, Inc.Mar 23, 2026
K260112 · QuikFix External Fixator: Knee-Spanning Pack
- Blue Ocean GlobalJan 20, 2026
K253291 · Excelsior System
- Stryker GmbHDec 19, 2025
K253202 · Hoffmann LRF System
- Paragon 28, Inc.Dec 19, 2025
K253613 · Monkey Rings External Ring Fixation System
- Medusa Orthopedics, LLCNov 25, 2025
K252555 · Medusa Orthopedics Boa External Fixation System
- Response Ortho Solutions, LLCNov 20, 2025
K252625 · The Response Ortho Smart Fixator - Hexapod System