Endo Model Modular Rotational Tibia - Small recall
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic…
Why was Endo Model Modular Rotational Tibia - Small recalled?
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI 04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large) Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111
- Product
- Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic…
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 3785
- Distribution
- Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)