CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
7 Hole VL Gridlock Fibula Plate recalled by Trilliant Surgical
Trilliant Surgical is recalling 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 Non-sterile Single Use Only, distributed in 7 states. The recall was initiated on 6 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2490-2015
- FDA event ID
- 71967
- Recalling firm
- Trilliant Surgical, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2015
- FDA classified
- 31 Aug 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2015 | Recall initiated by company | |
| 31 Aug 2015 | Classified by FDA | +25 days |
| 9 Sep 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
Questions about this recall
Is 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 Non-sterile Single Use Only recalled?
Yes. Trilliant Surgical recalled 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 Non-sterile Single Use Only on 6 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2490-2015.
Why was it recalled?
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.
Which lots are affected?
Lots: TSL002595, TSL002596, TSL002597
Where was it sold?
US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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