Manufacturer

Howmedica Osteonics Corp.

111 recalls in our database name Howmedica Osteonics Corp. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–111 of 111

HighFDA (Devices)·Z-1237-2022·2022-06-15
Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch
Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.
Product
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2022·2022-04-06
Ceramic Hip Femoral Head Component May Not Match Package Label
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Product
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2022·2022-04-06
Hip prosthetic femoral head component size and offset labeling mismatch
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2022·2022-02-23
Howmedica Osteonics Medical Device Packaging Defect: Tyvek Lid De-bonding Recall
Howmedica Osteonics is recalling medical devices because the outer Tyvek lid may separate from the package seal. This affects 32MM -4 V40 TAPER VIT HEAD devices distributed worldwide.
Product
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0652-2022·2022-02-23
Exeter V40 Cemented Hip Stem Labels May Mismatch Between Sizes
The FDA has recalled Exeter V40 Cemented Hip (150mm) Stems due to a potential labeling mix-up with the 125mm version. Patients who received the device should verify with their surgeon that the correct size was implanted.
Product
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0651-2022·2022-02-23
Exeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
Howmedica Osteonics is recalling Exeter V40 Cemented Hip (125mm) Stem devices due to a potential label mix with 150mm stems. Incorrect labeling could result in wrong implant size being used during surgery.
Product
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0645-2022·2022-02-23
Howmedica Dall Miles SM GRIP surgical device recalled for potential package de-bonding
Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.
Product
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0459-2022·2022-01-12
Surgical Instrument Tray Recalled for Incorrect Keel Punch Component
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Product
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthropl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0314-2022·2021-12-08
Orthopedic Implant Head Package Lid May Debond From Sealed Package
Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0313-2022·2021-12-08
Orthopedic implant hip component recalled in Puerto Rico
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2329-2021·2021-08-25
Triathlon orthopaedic implant baseplate recalled for assembly defect
Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.
Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Category
Medical Device
Distribution
Distributed nationwide