Z-0656-2013Class II

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40...

Name: Z-0656-2013 Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-10-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-10-23 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The... on 2012-10-23. FDA classified it as Class II and gives the reason as "Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0656-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-23
Posted: 2013-01-08
Terminated: 2013-09-11
Recalling firm: Howmedica Osteonics Corp
Product: Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions.
Quantity in commerce: 6021-2530- four units; 6021-3535-
Distribution: Nationwide distribution, including the states of NY, NJ, CA and FL.
Product codes and lots: Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0656-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-08

Product code MEH

K994366Class IITmzf Press Fit Ha Stem and Tmzf Press Fit Plus Ha StemHowmedica Osteonics Corp. / cleared 2000-03-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)