Z-2242-2016 Class II Terminated
FDA device recall Z-2242-2016 was initiated by Encore Medical, Lp on Jun 21, 2016 and is designated Class II. Reason for recall: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. The recall status is terminated (terminated Jan 10, 2017). Affected quantity: 14 (7 sets).
Recall details
- Product Type
- Devices
- Report Date
- Jul 27, 2016
- Initiation Date
- Jun 21, 2016
- Termination Date
- Jan 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 (7 sets)
Product description
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Reason for recall
Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
Distribution pattern
CO, ID, TX
Code information
Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2242-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026