Stryker Patella Assembly Instrument Recalled for Component Disassociation Risk
Stryker Howmedica Osteonics is recalling 2,039 units of the Scorpio Patella Assembly Instrument because press-fit failures could cause clamping components and pins to disassociate.
What this means for you
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 the hazard involves a surgical instrument where component disassociation could lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 2,039 units of the Stryker Orthopaedics Patella Assembly Instrument (REF 3182-1000, Non-Sterile). The device is used during total knee replacement surgery to implant Scorpio Patella implant components, specifically to fully seat the implant onto the bone and secure it in position while the surgeon removes excess cement and cement polymerization occurs.
The recall is due to a failure of the press-fit mechanism. Upon this failure, the clamping sub-components and pins could disassociate from the instrument. The affected units were distributed US Nationwide and Internationally.
Healthcare providers and consumers should stop using the affected instruments and contact Stryker Howmedica Osteonics Corp. for further instructions. The recall covers specific lot numbers listed in the official FDA notice.
The recalled product
- Product
- Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 2,039
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 No. 3182-1000 Lot #'s: RD8E100
- RD8A054TT
- RD8A054T
- RD8E099M
- RD8E099A
- RD8E099
- RD8A054A
- RD8E099D
- RD8A053A
- RD8A054
- RD8A053T
- RD7K062L
- RD8A052A
- RD8A052E
- RD8A052
- RD8A053
- RD7E128D
- RD5T290H
- RD7E128T
- RD5S262D
Distribution
Distributed nationwide across the United States.
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