The Recall Desk
SevereFDA (Devices)·Z-2393-2018·Announced 2018-07-18

Stryker Tibial Nail Recall Due to Potential Premature Breakage

Stryker GmbH is recalling specific Tibial Nails because non-conforming cannulation may reduce strength and cause premature breakage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (premature breakage) in an orthopedic implant, which poses a significant risk of injury.

Plain-English summary

Stryker GmbH is recalling 12 units of Tibial Nail, Standard T2 Tibia 12x315 mm (Product Number 18221231S). The recall involves units with GTIN 04546540197771 and Lot code K074846.

The manufacturer identified that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength, which could potentially lead to premature nail breakage.

The affected products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • GTIN 04546540197771
  • Lot code: K074846

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 16 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

Related recalls

Same manufacturer · Stryker GmbH

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Same hazard · structural failure

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