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Terminated

Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430

FDA Recall Z-1261-2007 · Posted 2007-09-26

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2006-03-13
Date Terminated2008-01-18
Product Quantity1,220 units

Reason for Recall

Dimensional anomaly

Firm Action

Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express.

Root Cause

Other

Distribution Pattern

Worldwide -USA, Romania, Chile and Brazil.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983382OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEMOsteonics Corp. · 1998-12-11

Official Source

View FDA Recall →

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

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