CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report
Tibial Nail, Standard T2 Tibia ¿ mm, Product Number 18221231S recalled
Stryker is recalling Tibial Nail, Standard T2 Tibia ¿ mm, Product Number 18221231S, distributed in 7 states. The recall was initiated on 27 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2393-2018
- FDA event ID
- 80131
- Recalling firm
- Stryker, Selzach
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2018
- FDA classified
- 10 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 27 Apr 2018 | Recall initiated by company | |
| 10 Jul 2018 | Classified by FDA | +74 days |
| 18 Jul 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Where it was distributed
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Questions about this recall
Is Tibial Nail, Standard T2 Tibia ¿ mm, Product Number 18221231S recalled?
Yes. Stryker recalled Tibial Nail, Standard T2 Tibia ¿ mm, Product Number 18221231S on 27 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2393-2018.
Why was it recalled?
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Which lots are affected?
GTIN 04546540197771; Lot code: K074846
Where was it sold?
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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