FDA-Device2015-11-25Class II
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.
Stryker Howmedica Osteonics Corp.
Hazard
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Sold states
Distribution to Virginia only.
Affected count
1 unit
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2016Don't want to check this manually?
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