Z-0467-2014Class II

1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica...

Name: Z-0467-2014 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-10-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-10-25 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430... on 2013-10-25. FDA classified it as Class II and gives the reason as "Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0467-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Posted: 2013-12-07
Terminated: 2015-03-31
Recalling firm: Howmedica Osteonics Corp
Product: 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution including states: AL, GA, IL, and WA.
Product codes and lots: 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-07

Product code JDI

K120578Class IIAccolade II Hip StemHowmedica Osteonics / cleared 2012-03-29

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)