Stryker Howmedica Osteonics Corp. recalls Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use d

Recalled November 25, 2015 · FDA recall Z-0281-2016 · Stryker Howmedica Osteonics

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. · FDA Class II

Units

1 unit

Sold at

Distribution to Virginia only.

Description

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.

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(s)

Stryker Howmedica Osteonics Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →