Extremities recall
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use…
Why was Extremities recalled?
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
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?
Product number: EL153B; GTIN: 00643169157248; Lot Number: 0009541707
- Product
- Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use…
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 41 units
- Distribution
- Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)