Delta Cup Beater Positioner - Aligner recall
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Why was Delta Cup Beater Positioner - Aligner recalled?
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
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 # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
- Product
- Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 20 units in (US)
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)