Z-1236-2008

Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For...

Name: Z-1236-2008 Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-11-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-11-15 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics... on 2007-11-15. The reason FDA records is "Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units". 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-1236-2008
Status: Terminated
Initiated: 2007-11-15
Posted: 2008-06-26
Terminated: 2010-01-25
Recalling firm: Howmedica Osteonics Corp
Product: Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product.
Quantity in commerce: 915 units
Distribution: Nationwide - USA
Product codes and lots: All Lot Codes for the following: Catalog # 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm.

Product code KWS

K061677Class IISolar Purefix Ha ShoulderHowmedica Osteonics Corp. / cleared 2006-07-10

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)