Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential material degradation of medical implants due to oxidation, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Ortho Development Corporation is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibial Insert components. The recall is due to improperly sealed foil pouches that allow air to seep back into the packaging after the sealing process.
The presence of air in the pouches increases the risk that the material properties of the implants will be substantially degraded due to oxidation. The affected products are UHMWPE components used in total knee arthroplasty (TKA) and revision TKA procedures to serve as a tibial bearing surface where additional joint constraint is needed.
The recall covers products distributed worldwide, including the United States and Japan. No military, government, or VA consignees are affected. Specific affected items include the CK Tibial Insert Size 6 12mm, Part 563-1612, Lot A135666. Healthcare providers and patients should contact Ortho Development Corporation for further instructions regarding the recall.
The recalled product
- Product
- Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
- Manufacturer
- Ortho Development Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- CK Tibial Insert Sz 6 12mm Part 563-1612
- Lot A135666
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ortho Development Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Ortho Development Corporation
See all →- HighOrtho Development Recalls Tibial Tray Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
- ModerateOrtho Development Recalls Tibial Tray Components Due to Manufacturing Defect
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- SevereOrtho Development Recalls Knee Implant Components Due to Sealing Defects
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
FDA (Devices) · 2014-08-27
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