Z-0281-2016Class II

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

Name: Z-0281-2016 Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-10-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-10-15 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2015-10-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0281-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-15
Posted: 2015-11-17
Terminated: 2017-06-08
Recalling firm: Howmedica Osteonics Corp
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.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.
FDA root cause: Under Investigation by firm
Action: 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 ([email protected] or Fax (1-866-672-0627 ) the response form back. Customers with questions were instructed to call 201.831.5272.
Quantity in commerce: 1 unit
Distribution: Distribution to Virginia only.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17

Product code JDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)