Z-2398-2018 Class II Terminated
FDA device recall Z-2398-2018 was initiated by Stryker GmbH on Apr 27, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 21, 2020). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2018
- Initiation Date
- Apr 27, 2018
- Termination Date
- May 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
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.
Distribution Pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Code Information
GTIN 04546540200402; Lot code: K08327D
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2398-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026