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Terminated

Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758

FDA Recall Z-1566-05 · Posted 2005-09-21

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-07-28
Date Terminated2007-04-19
Product Quantity93 primary units and 56 revision units

Reason for Recall

Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.

Firm Action

Recall was initiated by letter to sales agents on 07/28/2005.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041066ENCORE REVERSE SHOULDER PROSTHESISEncore Medical L.P. · 2005-03-24

Official Source

View FDA Recall →

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

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