| Date Initiated by Firm | September 14, 2015 |
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| Create Date | October 30, 2015 |
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| Recall Status1 |
Terminated 3 on November 04, 2016 |
| Recall Number | Z-0179-2016 |
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| Recall Event ID |
72229 |
| Product Classification |
Impactor - Product Code HWA
|
| 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. |
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| Code Information |
Lot # 52748L02A |
Recalling Firm/
Manufacturer |
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
|
| For Additional Information Contact | Teffany Hutto
512-834-6255 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| 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. |
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| Quantity in Commerce | 277 units |
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| Distribution | Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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