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Terminated

Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807

FDA Recall Z-0924-05 · Posted 2005-06-22

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-06-03
Date Terminated2005-07-13
Product Quantity54 USA 78 Europe

Reason for Recall

Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.

Firm Action

Notification was made by telephone beginning June 2, 2005. Recall is on-going.

Root Cause

Other

Distribution Pattern

Idaho, Texas and Virginia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022204VKS KNEE SYSTEMPlus Orthopedics · 2002-10-18

Official Source

View FDA Recall →

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

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