Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2015 - (Recall #: Z-0281-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 15, 2015

Date Posted: November 25, 2015

Recall Number: Z-0281-2016

Event ID: 72506

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

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 Pattern:

Distribution to Virginia only.

Voluntary or Mandated:

Voluntary: Firm initiated