Atlas FDA

TC-PLUS Tibial Insert UC 4; 11mm, Model 25427

FDA device recall Z-0015-06 · posted 2005-10-07 · Terminated

Recall details

Recalling firm
Plus Orthopedics USA
Reason for recall
Did not meet specifications.
Action taken
Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.
Root cause
Other
Status
Terminated
Product code
JWH
Quantity affected
9
Distribution
Arizona, California, Idaho, New York, Texas, and Virginia
Date initiated
2005-08-03
Date posted
2005-10-07
Date terminated
2006-06-16
Location
San Diego, CA

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Related 510(k) clearances

RecordFirmDate
TC-PLUS SOLUTION KNEE (K000666)Plus Orthopedics2000-10-13