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Terminated

7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.

FDA Recall Z-2490-2015 · Posted 2015-08-31

Recall StatusTerminated
Product CodeHRS
Date Initiated2015-08-06
Date Terminated2017-01-26
Product Quantity28 units

Reason for Recall

The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.

Firm Action

Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.

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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