Recall Z-0281-2016— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-10-15, terminated 2017-06-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-15
- Terminated
- 2017-06-08
- Firm location
- Mahwah, NJ, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.