CLASS II ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report
RipCord Syndesmosis Button recalled by TriMed
TriMed is recalling RipCord Syndesmosis Button, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 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-1101-2023
- FDA event ID
- 91478
- Recalling firm
- TriMed, Santa Clarita, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2022
- FDA classified
- 7 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 7 Feb 2023 | Classified by FDA | +47 days |
| 15 Feb 2023 | 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
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
RipCord Syndesmosis Button, REF: STA001K
Where it was distributed
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Nationwide AlabamaArkansasFloridaGeorgiaHawaiiIllinoisKansasLouisianaMissouriOhioPennsylvaniaTennesseeTexas
Questions about this recall
Is RipCord Syndesmosis Button recalled?
Yes. TriMed recalled RipCord Syndesmosis Button on 22 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1101-2023.
Why was it recalled?
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Which lots are affected?
UDI-DI: 00842188123849, Lot: 85305-01
Where was it sold?
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
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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