FDADecember 21, 2017device
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
What to do
FDA enforcement status: Terminated
Brands named
howmedica osteonicshowmedica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.2026-05-19
- FDATRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.2026-05-19
- FDAMICS3 Angled Sagittal Saw Attachment; Part Number: 2104902026-02-02
- FDAThe Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in...2025-11-12
- FDA1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;2025-08-28
- FDATriathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-2002024-09-04
- FDAMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090632024-08-07
- FDACustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;2024-08-05
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →