RSP Impaction Fixture recall
RSP Impaction Fixture
Why was RSP Impaction Fixture recalled?
During the Turon 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?
109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02
- Product
- RSP Impaction Fixture
- Recalling firm
- Encore Medical, Lp
- Quantity
- 626 units
- Distribution
- US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
- Recall date
- March 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)