Recall archive
92 recalls · page 1 of 4
Reported Jun 24, 2026
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2026
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which…
FDA (openFDA device enforcement)
Reported Dec 31, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this…
FDA (openFDA device enforcement)
Reported Oct 8, 2025
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and…
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging.…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2024
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
X3 TRIATHLON CS INSERT NO 3 10 MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Potential packaging breaches of inner blister and outer sterile blister.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can…
57 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size…
FDA (openFDA device enforcement)
Reported Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Howmedica Osteonics Corp.
Matched: Brand — Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal…
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the…
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — There is a potential for the outer Tyvek lid to de-bond from the sealed package.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro…
FDA (openFDA device enforcement)
Reported Dec 8, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — XXX
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal…
FDA (openFDA device enforcement)
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