—#119862

Product

00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052906
Affected lot / code info: Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096.

Why it was recalled

Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fract

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent a Urgent Medical Device Recall Notification letter August 1, 2013, and via E-mail and courier to all affected customers. The initial recall notice identified the reason for the recall, possible adverse risks and injuries and informed customers that a replacement will be available in the coming months. In addition, this letter will remind that the instrument is to be lubricated before each use and to inspect the foot. Customers are instructed to inspect any recalled product before and after use for cracks at the foot and ensure the foot is intact. Also ensure all moving parts are lubricated prior to each use according to the Recommendations for Care, Cleaning, Maintenance, and Sterilization Manual 97-5000-170-00. If you find a device which does not function properly or has a damaged foot, provide it to your Zimmer sales representative for return to Zimmer on a Product Experience Report (PER). Questions and concerns should be addressed to the Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST. Phase 2: As devices become available for distribution, a 2nd letter will be sent to the distributors and risk managers. Distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices will be included.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,

Timeline

Recall initiated: 2013-08-01
Posted by FDA: 2013-08-26
Terminated: 2015-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.