Fresh Recalls

FDAClass II · Medical device · Recall Z-2456-2026 · Recalled June 24, 2026

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall — Smith & Nephew, Inc.

Agency report date: June 24, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
Company / brand
Smith & Nephew
Lot / serial / date codes
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Distribution
International distribution to the countries of BE, DE, IT.
Agency product description and boundaries

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall status

3. Open the official notice or contact

Official recall ID
Z-2456-2026
Brand
All Smith & Nephew recalls
Classification
Class II
Units affected
5
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Memphis, TN, United States
Firm address
1450 E Brooks Rd, 38116-1804

Identifying details (verbatim from the notice)

Product codes / lots
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Distribution
International distribution to the countries of BE, DE, IT.
Firm notified the public via
Letter
FDA event ID
98629
Recall initiated
March 16, 2026
FDA classified
June 16, 2026
FDA report date
June 24, 2026

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 22, 2026 at 6:00 PM UTC.

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