Conformis, Inc. is recalling 3 units of the Identity Imprint PS Tibial Tray Size 4 because the packaging contains the wrong component. Specifically, a Size 5 Tibial Tray (Lot 508287) was accidentally placed inside a box labeled as Size 4 (Lot 540287). This error occurred during the final packing process, meaning a surgeon could receive a device that does not match the size indicated on the external label. These medical devices were distributed in Florida, Kansas, and New Hampshire.
If a surgeon relies on the box label, they may attempt to use an incorrectly sized tibial tray during surgery. This can lead to surgical delays while the correct size is located or, if not caught, a mismatch between the implant and the patient's anatomy which could require revision surgery.
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Sources: FDA iRES · Raw API Response
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