WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
FDA Recall Z-1924-2020 · Posted None
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHSN
Date Initiated2020-04-09
Date Terminated2020-11-02
Product Quantity22 units
Reason for Recall
One lot of INBONE Tibial Trays is missing the plasma coating.
Firm Action
The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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