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Orthofix TrueLok Hexapod System (TL-HEX) V2.0 recallZ-2063-2018 · Orthofix Srl · initiated Jan 30, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Orthofix Srl or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.

FDA root cause category: Device Design

What the company is doing

Customers were notified on approximately January 30, 2018, via letter. Instructions included to examine inventory for affected devices, remove any affected devices and arrange for the return of them, notify customers if the devices have been further distributed, and complete and return the response form. The notification also provided alternative procedures to complete the surgical intervention and treatment: 1) the surgeon can use parallel external support (either footplate or ring) that does not have dimensional issues; 2) the surgeon can complete fixation temporarily using non-hexapodal TrueLok connection elements, but the solution requires post-operative non-surgical intervention such as additional parallel external support that does not have dimensional issues or the surgeon completes the frame for treatment using TruLok non-hexapodal elements; 3) in case the issue arises in a strut changed during treatment, the surgeon can use an Emergency Tab Kit (see attached diagram in letter). For further questions, please call (214) 937-2000.

Recall details

Recall number
Z-2063-2018
Status
Terminated
Initiated by the company
Jan 30, 2018
Recalling firm
Orthofix Srl
Quantity
408 units
Product code
KTT
FDA submissions
K170650
Distribution
Worldwide Distribution - US Distribution within Texas., and to the countries of : Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Japan, South Africa, Spain, Sweden, Switzerland and United Kingdom.

Product description

TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a) 120 MM, Product Code 99-56-22000, Lot No. V1374370 (Lot No. laser marked on products V1369866, V1369865, V1369864), Exp. Date 06/08/2019, UDI 18054242512585;   b) 140 MM, Product Code 99-56-22020, Lot No. V1374298 (Lot No. laser marked on products V1369870, V1369868, V1369869, V1369872, V1369871), Exp. Date 06/07/2019, UDI 18054242512592;   c) 160 MM, Product Code 99-56-22040, Lot No. V1374255 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 06/07/2019, Lot No. V1374374 (Lot No. laser marked on products V1370130), Exp. Date 06/08/2019, Lot No. R1065030 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 12/16/2021, UDI 18054242512608;   d) 180 MM, Product Code 99-56-22060, Lot No. V1374259 (Lot No. laser marked on products V1370581, V1369468, V1369469, V1369467, V1369466, V1369465, V1369471, V1369470, V1370597), Exp. Date 06/07/2019, UDI 18054242512615;   e) 200 MM, Product Code 99-56-22080, Lot No. V1374361 (Lot No. laser marked on products V1369462, V1371128, V1371074, V1369463, V1370469), Exp. Date 06/08/2019, UDI 18054242512622;   f) 220 MM, Product Code 99-56-22100, Lot No. V1374373 (Lot No. laser marked on products V1369460, V1371250, V1371075), Exp. Date 06/08/2019, UDI 18054242512639

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

9 devices cleared under K170650 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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