Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device disassociation) where injury has not yet been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236. The recall involves specific lots of these medical devices that were distributed nationwide and to various foreign countries including Australia, Canada, and the United Kingdom.
The recall was initiated because the firm received a higher than expected number of complaints documenting femoral head/hip stem disassociation. This issue affects certain sizes of femoral heads manufactured prior to March 4, 2011. The source text does not specify the exact number of affected units or the specific sizes involved.
Healthcare providers and patients should check their inventory and patient records for the affected lot numbers listed in the official recall notice. If a patient has an affected device, they should contact their healthcare provider for guidance on monitoring or potential replacement.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · device disassociation
See all →- HighAtec Insignia Cervical Plate Screw Locking Mechanism May Fail
FDA (Devices) · 2021-06-16
- HighNuvasive Precice Bone Transport System Recall for Distal Plug Disassociation Risk
FDA (Devices) · 2020-10-14
- HighHowmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
FDA (Devices) · 2018-07-11
- HighHowmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
FDA (Devices) · 2018-07-11
Similar recalls
- ModerateStryker Recalls V40 Femoral Heads Due to Assembly Issues
FDA (Devices) · 2015-03-11
- HighCeramic Hip Femoral Head Component May Not Match Package Label
FDA (Devices) · 2022-04-06
- HighStryker Vitallium Femoral Heads Recalled Due to Assembly Failure
FDA (Devices) · 2015-11-18
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighHip prosthetic femoral head component size and offset labeling mismatch
FDA (Devices) · 2022-04-06
- LowBiomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling
FDA (Devices) · 2015-06-17