Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
Stryker Howmedica Osteonics is recalling specific lots of LFIT Anatomic V40 Femoral Heads because of reported taper lock failures that caused harm.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that Stryker received complaints describing the 'incidence of harm' secondary to the defect. Under the severity rubric, a Class II recall with significant injury or harm reports is classified as Severe (Score 4).
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic V40 Femoral Heads, Low Friction Ion Treatment, Sterile. The recall covers 42,519 units of modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement. The affected catalog numbers include 6260-9-236, 6260-9-240, 6260-9-244, 6260-9-340, 6260-9-440, 6260-9-344, and 6260-9-444, with manufacturing dates ranging from 1/1/06 to 3/4/11, and one lot from 1/102 to 7/1/10.
The recall was initiated after Stryker received several complaints describing the incidence of harm secondary to taper lock failure for specific lots of these femoral heads. The hazard involves the mechanical failure of the connection between the femoral head and the hip stem trunnion.
The affected products were distributed US Nationwide and Internationally. Healthcare providers and patients should contact Stryker Howmedica Osteonics Corp. for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 42,519
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Catalog #6260-9-236 - Head Diameter 36 mm
- Offset +5
- including all lots manufactured from 1/102 - 7/1/10
- Catalog #6260-9-240 - Head Diameter 40 mm
- Offset +4
- including all lots manufactured from 1/1/06 - 3/4/11
- Catalog #6260-9-244 - Head Diameter 44 mm
- Catalog #6260-9-340 - Head Diameter 40 mm
- Offset +8
- Catalog #6260-9-440 - Head Diameter 40 mm
- Offset +12
- Catalog #6260-9-344 - Head Diameter 44 mm
- including all lots manufactured from 1/1/06 - 3/4/11.
Distribution
Distributed nationwide across the United States.
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