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Terminated

HA Hip Stem, cementless

FDA Recall Z-1128-04 · Posted 2004-07-22

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJDI
Date Initiated2004-06-30
Date Terminated2004-10-21
Product Quantity3 units

Reason for Recall

Hip stem product was mis-labeled with wrong size.

Firm Action

Firm sent letter of notification to consignee on 6/30/2004.

Root Cause

Other

Distribution Pattern

Deerfield Beach, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993943ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HAEncore Orthopedics, Inc. · 2000-02-04

Official Source

View FDA Recall →

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

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