Stryker Recalls PCA Acetabular Inserts Due to Regulatory Omission
Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.
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, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling six units of the PCA 10 Degree Hooded Acetabular Insert, ID 22mm. This product is part of the Howmedica PCA Total Hip System and is intended for use during total hip arthroplasty to restore hip joint biomechanics.
The recall was initiated because the 22 mm size of the insert was inadvertently omitted from FDA 510(k) clearance number K963612. This is a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The affected units were distributed to Virginia only. Specific catalog and lot numbers are listed in the official recall documentation. Healthcare providers and facilities that may have received these units should contact Stryker Howmedica Osteonics Corp. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 1
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 (7)
- Catalog Number:Lot Number
- 6299-8-403:23182601
- 6299-8-469:19123701
- 6299-8-525:29115601
- 6299-8-525:22727301
- 6299-8-581:17772401
- 6299-8-581:28432001.
Distribution
Distributed in 1 state:
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