Z-1365-2009

Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves...

Name: Z-1365-2009 Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-01-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-01-06 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree... on 2009-01-06. The reason FDA records is "Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1365-2009
Status: Terminated
Initiated: 2009-01-06
Posted: 2009-07-22
Terminated: 2012-06-25
Recalling firm: Howmedica Osteonics Corp
Product: Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
Quantity in commerce: 1,628 total stems, all varieties.
Distribution: Nationwide Distribution.
Product codes and lots: 6021-0335 ACCOLADE (127 DEG) SIZE 3 24295205 6021-0335 ACCOLADE (127 DEG) SIZE 3 24319601 6021-0335 ACCOLADE (127 DEG) SIZE 3 24859104 6021-0335 ACCOLADE (127 DEG) SIZE 3 24991703 6021-0335 ACCOLADE (127 DEG) SIZE 3 25006601 6021-0335 ACCOLADE (127 DEG) SIZE 3 25022201 6021-0335 ACCOLADE (127 DEG) SIZE 3 25045503 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069901 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069902 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069904 6021-0335 ACCOLADE (127 DEG) SIZE 3 25108801 6021-0335 ACCOLADE (127 DEG) SIZE 3 25108802 6021-0335 ACCOLADE (127 DEG) SIZE 3 25169501 6021-0335 ACCOLADE (127 DEG) SIZE 3 25169502 6021-0335 ACCOLADE (127 DEG) SIZE 3 25190102 6021-0335 ACCOLADE (127 DEG) SIZE 3 25211202 6021-0335 ACCOLADE (127 DEG) SIZE 3 25231203 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245201 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245202 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245203 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245204 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255401 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255402 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255403 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255404 6021-0335 ACCOLADE (127 DEG) SIZE 3 25309704 6021-0335 ACCOLADE (127 DEG) SIZE 3 25348701 6021-0335 ACCOLADE (127 DEG) SIZE 3 25400905 6021-0335 ACCOLADE (127 DEG) SIZE 3 25400906 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428401 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428402 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428403 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428404 6021-0335 ACCOLADE (127 DEG) SIZE 3 25459601 and 6021-0335 ACCOLADE (127 DEG) SIZE 3 25467303.

Product code MEH

K023102Class IIAccolade Tmzf Plus Ha 127 Size 0 Hip StemHowmedica Osteonics Corp. / cleared 2002-10-09

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)