Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.
FDA Recall Z-1685-2009 · Posted 2009-08-13
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2007-05-29
Date Terminated2009-08-17
Product Quantity2 units
Reason for Recall
Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301
Firm Action
Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069.
For further questions, contact Stryker Orthopaedics at 1-201-831-5825.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed to 2 Stryker branches.
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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