FDA Device recall Z-2265-2018
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08 by Trimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2265-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-13 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Trimed |
| Distribution | CA, FL, IL, KS, MN, MO, MS, NC, NJ, NV, PA, TX, UT, WA |
Product
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Reason
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.
Identifiers
| code_info | Lot #: a) 021C, 00T3, 050501, 10505-01, 00501, 179201, 17920, 179202, 179203; b) 26401, 0219, 02613, 0216,…Lot #: a) 021C, 00T3, 050501, 10505-01, 00501, 179201, 17920, 179202, 179203; b) 26401, 0219, 02613, 0216, 026B, 050502, 10505-02, 01P2, 24601, 179302, 179301, 179303, 264-01, 179304, 317003; c) R884, 0266, 050503, 10505-03, 179501, 004J, 00A0, 173501; d) 26402, 264-02, 2015, 050508, 10505-08, 24602, 11799, 23402, 0215, 1799, 179901, 179304, 1179; e) 26403, 03UQ, 050509, 10505-09, 24603, 11802, 1180202, 180202, 80202, 180203, 108202, 263401, 23401; f) 004K, 0093; g) 004L, 2012BB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2265-2018%22
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