Orthofix Recalls TL-HEX TruLok Hexapod System Due to Incompatibility
Orthofix Srl is recalling 408 units of TL-HEX TruLok Hexapod System double row footplates because they are incompatible with current struts, posing a risk of dimensional interference.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (incompatibility/dimensional interference) that poses a risk of harm during surgical use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthofix Srl is recalling 408 units of the TL-HEX TruLok Hexapod System, specifically the Double Row Footplates in sizes 120 MM, 140 MM, 160 MM, 180 MM, and 200 MM. The recall involves specific lots manufactured in a limited period in 2014. The product is a metal bone fixation device used for stabilization and correction during the healing process.
The recall was initiated after the firm received complaints regarding incompatibility and dimensional interference between the double row footplates 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.
The affected units were distributed worldwide, including within Texas, USA, and to Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Japan, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Physicians and healthcare facilities should stop using the affected footplates and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- 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.…
- Manufacturer
- Orthofix Srl
- Affected units
- 408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
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