CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report
Hex Cortical Screw recalled by TriMed
TriMed is recalling TriMed Hex Cortical Screw 0, distributed in Florida, Missouri. The recall was initiated on 24 Aug 2018 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-1214-2019
- FDA event ID
- 82209
- Recalling firm
- TriMed, Santa Clarita, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2018
- FDA classified
- 23 Apr 2019
- Reported
- 1 May 2019
- 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
| 24 Aug 2018 | Recall initiated by company | |
| 23 Apr 2019 | Classified by FDA | +242 days |
| 1 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The bone screw is shorter than the intended design specification.
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
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.
Where it was distributed
US Distribution to states of FL and MO.
Questions about this recall
Is Hex Cortical Screw 0 recalled?
Yes. TriMed recalled Hex Cortical Screw 0 on 24 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-1214-2019.
Why was it recalled?
The bone screw is shorter than the intended design specification.
Which lots are affected?
Lot #170281, UDI (01)00842188107108(11)170406(10)170281
Where was it sold?
US Distribution to states of FL and MO.
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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