Z-2456-2026Class II

Trigen Proximal Straight Humeral Nail 8/7 X 16, Ref: 71760816

Name: Z-2456-2026 Trigen Proximal Straight Humeral Nail 8/7 X 16, Ref: 71760816
Creator: Smith & Nephew, Inc.
Published: 2026-03-16
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2026-03-16 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 on 2026-03-16. FDA classified it as Class II and gives the reason as "Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2456-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-16
Posted: 2026-06-16
Recalling firm: Smith & Nephew, Inc.
Product: Trigen Proximal Straight Humeral Nail 8/7 X 16, Ref: 71760816
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 3/16/2026, recall notices were emailed to customers who were asked to do the following: 1) Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this Field Action and provide to them a copy of this letter. 3. Please complete the Customer Response form and email or fax it to your national Smith+Nephew agency/distributor. 4. Return quarantined product to your national Smith+Nephew agency/distributor. 5. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. Firm contact information: + 1 901 396 2121, 1 800 821 5700
Quantity in commerce: 5
Distribution: International distribution to the countries of BE, DE, IT.
Product codes and lots: UDI-DI: 03596010514394. Lot/Batch: 25BM03616

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2456-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2456-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-16

Product code HSB

K210980Class IISmith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. / cleared 2022-11-14

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)