Z-0179-2016 Class II Terminated
FDA device recall Z-0179-2016 was initiated by Encore Medical, Lp on Sep 14, 2015 and is designated Class II. Reason for recall: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray… The recall status is terminated (terminated Nov 4, 2016). Affected quantity: 277 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 4, 2015
- Initiation Date
- Sep 14, 2015
- Termination Date
- Nov 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 277 units
Product description
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
Reason for recall
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Distribution pattern
Nationwide Distribution
Code information
Lot # 52748L02A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0179-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026