Stryker Howmedica Osteonics Corp. ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Product No. 5351-4507 to 5351-4515, 5351-4608. 5351-4610 and 5351-4612. All lot codes.
Products Sold
Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.
Stryker Howmedica Osteonics Corp. is recalling ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to due to The plasma spray may delaminate from the proximal portion of the humeral stem.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The plasma spray may delaminate from the proximal portion of the humeral stem.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, OH
Page updated: Jan 10, 2026