Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use duri

FDA device recall Z-0281-2016 · posted 2015-11-17 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

Stryker sent an Urgent Medical Device Recall Notification letter dated October 15, 2015, to all affected customers. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were instructed to quarantine the affected product. Consignees were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers with questions were instructed to call 201.831.5272.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JDI

Quantity affected

1 unit

Distribution

Distribution to Virginia only.

Date initiated

2015-10-15

Date posted

2015-11-17

Date terminated

2017-06-08

Location

Mahwah, NJ