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Terminated

Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325

FDA Recall Z-1241-2007 · Posted 2007-09-21

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-10-17
Date Terminated2009-07-07
Product Quantity3 total, 2 in USA

Reason for Recall

Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

Firm Action

Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.

Root Cause

Other

Distribution Pattern

Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920034DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPACPfizer Hospital Products Group, Inc. · 1992-03-18

Official Source

View FDA Recall →

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

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