00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem L

FDA device recall Z-1092-2014 · posted 2014-02-26 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.

Action taken

Zimmer sent an Urgent Medical Device Recall dated January 10, 2014 to distributors via electronic mail. The hospital/surgeon that has implanted this manufacturing lot will be identified and notified by the distributor. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to locate and remove the affected product in their territory, as well as identifying and notifying the hospital/surgeon that has implanted this manufacturing lot as applicable. The distributor will return on-hand affected products to Zimmer and ensure all of their products are accounted for using the return form provided in the letter. Distributors and hospital consignees are to complete and return the inventory return form and acknowledgement form indicating which hospital/surgeon has implanted the product and to which they have provided notice to. Email a copy of the completed return form to CorporateQuality.PostMarket@Zimmer.comCommunications outside of the United States will occur approximately two weeks after the United States communications. For questions call 1-877-946-2761

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KWT

Quantity affected

10 units

Distribution

Distribution USA in the state of Illinois.

Date initiated

2014-01-10

Date posted

2014-02-26

Date terminated

2014-09-11

Location

Warsaw, IN

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