Ortho Development Corporation Recall: Tibila Insert UC, Balanced Knee System, REF163-3YYY
Ortho Development Corporation Recall: Tibila Insert UC, Balanced Knee System, REF163-3YYY is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho Development Corporation; Product: Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures t
| Recalling firm | Ortho Development Corporation |
|---|---|
| Product | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component |
| Reason for recall | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. |
| Recall initiated | 20140711 |
| Recall number | Z-2256-2014 |
| Category | device |
| State | UT |
| Country | United States |
$29/mo
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