Z-0179-2016Class II

Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the...

Name: Z-0179-2016 Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the...
Creator: Encore Medical, Lp
Published: 2015-09-14
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2015-09-14 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of 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... on 2015-09-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0179-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-10-30
Terminated: 2016-11-04
Recalling firm: Encore Medical, LP
Product: 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.
Product code: HWA Impactor
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.
Root cause tag: design
FDA root cause: Device Design
Action: DJO Global sent an Urgent Field Safety Notice dated September 15, 2015, to all affected consignees. The notice identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed become familiar with the new techniques and notify all of their applicable users of the RSP Monoblock and Turon stems of these revised methods. When each user has been notified of these new techniques, they should complete the form that was provided with the notification indicating that they have been informed of these changes and understand the new methods. Consignees were asked to complete and return forms. Consignees with questions should call 512-834-6255.
Quantity in commerce: 277 units
Distribution: Nationwide Distribution
Product codes and lots: Lot # 52748L02A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0179-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-28
Z-0180-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-28

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)