Z-2264-2018Class II

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c)...

Name: Z-2264-2018 Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c)...
Creator: TriMed Inc.
Published: 2018-04-13
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-04-13 / Terminated / root cause: manufacturing process

FDA source

TriMed Inc. began a recall of 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)... on 2018-04-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2264-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-13
Posted: 2018-06-20
Terminated: 2021-01-22
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
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 706
Distribution: U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20
Z-2263-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20
Z-2264-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20
Z-2265-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20

Product code JDR

K112794Class IIEos Small Bone Fixation SystemTriMed, Inc. / cleared 2012-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)