FDA Medical Device Recalls (openFDA)
TriMed Inc.: Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
- Recall number
- Z-2264-2018
- Recalling firm
- TriMed Inc.
- Product
- Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
- 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
- 706
- 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) 00A5, 26406, R889, 03UJ, 003UJ, 050514, 10505-14, 264-06, 004P, 26404, 10505-14, 226001, 264, 26401, 22600; b) 004S; c) 004R; d) 050518, 10505-18, 021G, 021F, 0505018, 11788, 080818, 178801, 17881, 316801; e) R895, 050519, 10505-19, 2012BJ, 004V, 009D, 0505019, 178901, 180502, 17890, 1178901, 00AB, 0090, 0091, 78901; f) 009E, 11264, R896, 004W, 183701, 11837, 050520, 10505-20, 178901, 10505-20, 083701, 118337, 08370, 26407, 264-07; g) 03UR, 26408, 264-08, 050521, 26406, 264-06, 1050521, 179001, 10505-21, 179002
- 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