Recall archive
92 recalls · page 2 of 4
Reported Apr 14, 2021
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the…
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a…
FDA (openFDA device enforcement)
Reported May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package…
15 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2020
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in…
FDA (openFDA device enforcement)
Reported Jan 22, 2020
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
FDA (openFDA device enforcement)
Reported Dec 4, 2019
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
FDA (openFDA device enforcement)
Reported Oct 9, 2019
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2019
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were…
FDA (openFDA device enforcement)
Reported Jan 2, 2019
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand · Product details — Potential for outer pouch sterile barrier to be compromised
FDA (openFDA device enforcement)
Reported Oct 31, 2018
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the…
FDA (openFDA device enforcement)
Reported Aug 15, 2018
Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at…
69 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 8, 2018
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings…
FDA (openFDA device enforcement)
Reported Jul 11, 2018
LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of…
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Customers may receive the incorrect size implant from what is labeled on the box.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Inner and outer sterile barriers not fully sealed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
FDA (openFDA device enforcement)
Reported May 31, 2017
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Reunion TSA Peg Alignment Sound broke during surgery.
FDA (openFDA device enforcement)
Reported Dec 28, 2016
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is…
FDA (openFDA device enforcement)
Reported Nov 16, 2016
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of…
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal…
FDA (openFDA device enforcement)
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