ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Reported: October 28, 2015 Initiated: August 31, 2015 #Z-0147-2016
Product Description
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Reason for Recall
May contain small amounts of ethylene glycol residue
Details
- Recalling Firm
- ConforMIS, Inc.
- Units Affected
- 110 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111. Recalled by ConforMIS, Inc.. Units affected: 110 units.
Why was this product recalled? ▼
May contain small amounts of ethylene glycol residue
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0147-2016.
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