Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
FDA Recall Z-1102-2010 · Posted 2010-03-11
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2009-12-30
Date Terminated2012-09-14
Product Quantity1
Reason for Recall
The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.
Firm Action
Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.
Root Cause
Process control
Distribution Pattern
1 device distributed to a hospital in GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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