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Terminated

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

FDA Recall Z-1236-2008 · Posted 2008-06-26

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWS
Date Initiated2007-11-15
Date Terminated2010-01-25
Product Quantity915 units

Reason for Recall

Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide - USA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061677SOLAR PUREFIX HA SHOULDERHowmedica Osteonics Corp. · 2006-07-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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