FDA (Devices) recall action 67503
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat components due to discoloration caused by premature oxidation.
Zimmer, Inc. is recalling 3,638 units of MOST Options System hinged tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.
Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide due to discoloration caused by premature oxidation during storage.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II Constrained Knee System tibia components due to discoloration caused by premature oxidation.
Zimmer, Inc. is recalling 3,638 Natural-Knee/Apollo knee implants because a component was discolored due to premature oxidation.
Zimmer, Inc. is recalling specific Natural-Knee II unicompartmental knee system tibia components due to discoloration caused by premature oxidation during storage.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II System components due to discoloration caused by premature oxidation. The affected devices were stored in transparent containers exposed to light.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II knee prostheses because a component was found to be discolored due to premature oxidation.
Zimmer, Inc. is recalling 3,638 Natural-Knee II Posterior Stabilized Condylar Tibial Inserts because free radical oxidation caused discoloration.
Zimmer, Inc. is recalling 3,638 Apollo Knee System tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.
Zimmer, Inc. is recalling 3,638 Apollo Revision/Constrained Knee System tibia inserts because they were discolored due to premature oxidation during storage.
Zimmer, Inc. is recalling 3,638 Apollo Knee Tibial Baseplates and Inserts because free radical oxidation caused discoloration in some units.
Zimmer, Inc. is recalling 3,638 units of Apollo Knee System patella components due to discoloration caused by premature oxidation during storage.
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.
Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.