CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R recalled
TriMed is recalling Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, distributed in 14 states. The recall was initiated on 13 Apr 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-2262-2018
- FDA event ID
- 80099
- Recalling firm
- TriMed, Santa Clarita, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 20 Jun 2018
- Reported
- 27 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 20 Jun 2018 | Classified by FDA | +68 days |
| 27 Jun 2018 | 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
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
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
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Where it was distributed
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
CaliforniaFloridaIllinoisKansasMinnesotaMissouriMississippiNorth CarolinaNew JerseyNevadaPennsylvaniaTexasUtahWashington
Questions about this recall
Is Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R recalled?
Yes. TriMed recalled Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R on 13 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2262-2018.
Why was it recalled?
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Which lots are affected?
Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ, 10505-23, 050523, 180502, 180901, 180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805, 180502, 118901
Where was it sold?
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
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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