[Recalled] Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented,
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert |
|---|---|
| Brand / manufacturer | Orthopedic Alliance LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1379-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 February 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Orthopedic Alliance LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.