Device product
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Z-2393-2018
Product summary
- Firm
- Stryker GmbH
- Event
- Event 80131
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-2393-2018
Official wording
Reason: 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.
Code information: GTIN 04546540197771; Lot code: K074846
Distribution pattern: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Derived failure modes
-
Potency or specification failure
out-of-specification