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Terminated

Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121

FDA Recall Z-0360-2008 · Posted 2007-12-08

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeKTT
Date Initiated2003-06-30
Date Terminated2007-12-13
Product Quantity3

Reason for Recall

The device was produced without the required distal locking hole

Firm Action

The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.

Root Cause

Reprocessing Controls

Distribution Pattern

Nationwide: AZ and ID

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020240SLIM GLIDING NAIL SYSTEMPlus Orthopedics · 2002-02-22

Official Source

View FDA Recall →

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

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