Stryker Vitallium Femoral Heads Recalled Due to Assembly Failure
Stryker Howmedica Osteonics Corp. is recalling 201 Vitallium femoral heads because they could not be assembled with their corresponding stems during surgery.
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) where a functional failure occurred during surgery, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 201 units of Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. These are components used in hip prosthesis surgeries. The recall is due to complaints that the femoral heads could not be assembled with their corresponding V40 stem trunnions at the time of surgery.
The affected products are identified by specific catalog numbers and expiration dates ranging from July 2019 to August 2019. The recall covers a nationwide distribution of these medical device components.
Healthcare providers and patients should contact Stryker Howmedica Osteonics Corp. for further instructions regarding the replacement or return of these specific femoral heads.
The recalled product
- Product
- Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 201
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 (20)
- Catalog Numbers 6260-5-028
- 6260-5-032
- 6260-5-132
- 6260-5-232
- 232
- 6260-5-328
- 6260-5-332
- 6260-5-428
- 6260-5-432
- 6260-9-0928
- 6260-9-032
- 6260-9-132
- 6260-9-232
- 6260-9-328
- 6260-9-332
- 6260-9-428
- 6280-0-128
- 6280-0-228
- 6280-0-232
- 6280-0-332 exp- dates july 2019 to august 2019
Distribution
Distributed nationwide across the United States.
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