CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
Trigen, Intramedullary nail recalled by Smith & Nephew
Smith & Nephew is recalling Trigen, Intramedullary nail, distributed nationwide in the US. The recall was initiated on 24 Jun 2020 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-2685-2020
- FDA event ID
- 85920
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2020
- FDA classified
- 22 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Jun 2020 | Recall initiated by company | |
| 22 Jul 2020 | Classified by FDA | +28 days |
| 29 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
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
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Where it was distributed
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Questions about this recall
Is Trigen, Intramedullary nail recalled?
Yes. Smith & Nephew recalled Trigen, Intramedullary nail on 24 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2685-2020.
Why was it recalled?
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Which lots are affected?
Model: 71655139 Lot: 19BM13592A
Where was it sold?
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
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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