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Terminated

ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp.

FDA Recall Z-0080-2008 · Posted 2007-11-01

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWS
Date Initiated2007-05-09
Date Terminated2008-03-07
Product Quantity232 units

Reason for Recall

The plasma spray may delaminate from the proximal portion of the humeral stem.

Firm 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.

Root Cause

Process control

Distribution Pattern

One hospital in Akron OH and 12 Stryker branches/agencies

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062113SOLAR REUNION FRACTURE STEMHowmedica Osteonics Corp. · 2006-10-03

Official Source

View FDA Recall →

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

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