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Terminated

Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.

FDA Recall Z-1004-2009 · Posted 2009-04-21

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLPH
Date Initiated2008-11-21
Date Terminated2011-11-21
Product Quantity19 units

Reason for Recall

Liners measuring 28 mm ID and were mismarked as 32 mm.

Firm Action

All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.

Root Cause

Process control

Distribution Pattern

International Distribution to Canada, France, Germany and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSSmith & Nephew, Inc. · 1999-10-22

Official Source

View FDA Recall →

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

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