Z-0080-2008

ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm...

Name: Z-0080-2008 ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-05-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-05-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray... on 2007-05-09. The reason FDA records is "The plasma spray may delaminate from the proximal portion of the humeral stem". 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-0080-2008
Status: Terminated
Initiated: 2007-05-09
Posted: 2007-11-01
Terminated: 2008-03-07
Recalling firm: Howmedica Osteonics Corp
Product: ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The plasma spray may delaminate from the proximal portion of the humeral stem.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.
Quantity in commerce: 232 units
Distribution: One hospital in Akron OH and 12 Stryker branches/agencies
Product codes and lots: Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.

Product code KWS

K062113Class IISolar Reunion Fracture StemHowmedica Osteonics Corp. / cleared 2006-10-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)