CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing prima

FDA device recall Z-1135-2105 · posted 2015-02-20 · Terminated

Recall details

Recalling firm

Zimmer Gmbh

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Action taken

On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-800-348-2759.

Root cause

Package design/selection

Status

Terminated

Product code

MEH

Quantity affected

6109

Distribution

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Internation

Date initiated

2014-12-17

Date posted

2015-02-20

Date terminated

2015-09-23

Location

Winterthur, Switzerland

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