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Terminated

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

FDA Recall Z-2242-2016 · Posted 2016-07-19

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLPH
Date Initiated2016-06-21
Date Terminated2017-01-10
Product Quantity14 (7 sets)

Reason for Recall

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Firm Action

The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.

Root Cause

Process design

Distribution Pattern

CO, ID, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974294ENCORE LINEAR POROUS COATED HIPEncore Orthopedics, Inc. · 1998-01-12

Official Source

View FDA Recall →

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

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