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Howmedica Osteonics Recalls
232 recalls on record · September 21, 2016 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 15, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius i
Hazard: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
August 15, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in t
Hazard: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
August 15, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in t
Hazard: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
August 15, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in t
Hazard: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
August 15, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Str
Hazard: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
August 8, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Custom Made Implant System with Minimum Invasive Grower (MIG) component
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.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
July 11, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Hazard: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 2, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision
Hazard: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
May 2, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use d
Hazard: Customers may receive the incorrect size implant from what is labeled on the box.
March 21, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740
Hazard: Inner and outer sterile barriers not fully sealed.
March 21, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Hazard: Inner and outer sterile barriers not fully sealed.
March 7, 2018Medical DevicesFDA
Howmedica Osteonics Corp. recalls AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to all
Hazard: 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.
September 21, 2016Medical DevicesFDA
Howmedica Osteonics Corp. recalls AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebr
Hazard: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.
September 21, 2016Medical DevicesFDA
Howmedica Osteonics Corp. recalls AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebra
Hazard: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.
September 21, 2016Medical DevicesFDA
Howmedica Osteonics Corp. recalls AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral
Hazard: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.