Reverse Shoulder Prosthesis Stem Impaction Fixture recall
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back…
Why was Reverse Shoulder Prosthesis Stem Impaction Fixture recalled?
During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 52748L02A
- Product
- Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back…
- Recalling firm
- Encore Medical, Lp
- Quantity
- 634 units
- Distribution
- Nationwide Distribution
- Recall date
- November 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)