Z-0626-2016 Class II Terminated
FDA device recall Z-0626-2016 was initiated by Encore Medical, Lp on Dec 8, 2015 and is designated Class II. Reason for recall: The trial shell mating feature on the broach is undersized. The recall status is terminated (terminated Mar 1, 2016). Affected quantity: 23 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Dec 8, 2015
- Termination Date
- Mar 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product description
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Reason for recall
The trial shell mating feature on the broach is undersized.
Distribution pattern
Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Code information
178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0626-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026