FDA Medical Device Recalls (openFDA)
TriMed Inc.: 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
- Recall number
- Z-2265-2018
- Recalling firm
- TriMed Inc.
- 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
- Status
- Terminated
- Initiated
- 2018-04-13
- Posted
- not on file
- Terminated
- 2021-01-22
- 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.
- Root cause
- Process design
- Action
- On 04/13/18, customer recall communication forms were sent via mail informing customers to quarantine effected devices, call the manufacturer to arrange device return at 800-633-7221, and report adverse events to the FDA's MedWatch.
- Quantity
- 1,194
- Distribution
- U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K112794"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3001236812
- Firm city
- Santa Clarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28