Zimmer Recalls Specific Lot of Shoulder Humeral Stems

Zimmer Holdings Inc. has issued a recall for lot #62267250 of its Trabecular Metal Shoulder Humeral Stem 48 Degrees, according to a company news release.

According to the voluntary notification, the specified lot’s bond strength between the Trabecular Metal material and substrate potentially could be below the minimum required specification. The stems were distributed between Feb. 8, 2013, and April 26, 2013. In testing from the specified lot, one of the three zones of the trabecular metal was 80 percent of the minimum-required bond strength. Two other zones exceeded the minimum bond-strength specifications.

Only the affected product lot was reported to have substandard bond strength and no related patient injuries have been reported, according to the announcement. The company noted the “potential that the Trabecular Metal dis-bonds from the stem substrate. Dis-bonding could cause implant loosening and increased wear that potentially could require revision surgery” as a risk of the specific lot.