Zimmer Avoids Hip Recall, Suspends Product
In 2008, after reports of high failure rates in its Durom Cup hip implant, Zimmer Holdings Inc. opted to voluntarily suspend sales of the device. A study by Dr. Lawrence Dorr revealed that approximately 8.5% of patients who had received the Durom Cup implant had required hip revision within two years of their initial surgery; some had contacted a Zimmer hip lawyer for possible claims against the manufacturer.
Classifications for FDA Recall
After reviewing the Durom Cup hip implant, Zimmer announced that the device was in working order and that any problems were due to improper surgical techniques. Zimmer emphasized that it had only issued “a suspension of sales,” and not a full or partial Zimmer hip recall.
The Food and Drug Administration (FDA) has three classifications for product recall: Class I, Class II, and Class III. Class I is the highest classification, and represents products that the FDA determines “will cause serious health problems or death.” In the event of a Class I recall, Zimmer would be required to notify both its customers and implant recipients of the recall and the reasons for it, and would also be required to take steps to minimize risks associated with the recall.
Class II and III recalls are less serious than Class I. The FDA’s Class II recall governs devices that may cause serious health problems. In this were the case, Zimmer Holdings Inc. would inform its customers of the recall, but would not be required to contact recipients of the Durom Cup. A Class III recall is usually issued if the FDA finds that a device manufacturer has violated an FDA regulation.
FDA Issues Warning
Zimmer Holdings Inc. has not been ordered to issue a Durom Cup hip recall. However, in February 2011, the FDA issued a public announcement regarding metal-on-metal device implants and their possible risks. Three months later, in May 2011, the FDA ordered all metal-on-metal device manufacturers to conduct studies regarding the post-market and long-term performance of their implants. Zimmer was among the manufacturers to receive the order.
A future Zimmer hip recall would influence current legislation. Many a Zimmer hip lawsuit has already been initiated in national court, and since June 2009, those meeting requirements have been routed to federal multidistrict litigation (MDL) in New Jersey.