Stryker Omnifit Crossfire Hip Insert Recall Due to Missing Locking Wire
Howmedica Osteonics Corp. is recalling 20 units of Stryker Omnifit Crossfire 10 Degree Series II Inserts due to a potential missing locking wire.
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 is classified as FDA Class II and involves a risk-of-harm product (missing locking wire) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Howmedica Osteonics Corp. is recalling 20 units of the Stryker Omnifit Crossfire 10 Degree Series II Insert, Catalog # 2041C-3254. The product is intended for cementless and/or cemented fixation within the prepared acetabulum. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the devices may have a missing locking wire. This defect may cause a delay in surgery while a back-up device is retrieved, or it may result in the implantation of a device that is missing a locking wire. The affected lot number is 53778501.
The recalled units were distributed to facilities in California, Florida, Georgia, Iowa, Massachusetts, Michigan, North Carolina, Ohio, and Wisconsin, as well as to Canada and Japan. Healthcare providers should check their inventory for this specific lot number and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 20
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 (1)
- Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501
Distribution
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