Recall Z-0068-2014— Zimmer, Inc.

Name: FDA recall Z-0068-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-08-30, terminated 2014-09-25. It names one FDA 510(k) clearance: K833991. Product: Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.. Reason: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Terminated: 2014-09-25
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K833991 — BIPOLAR HIP DEVICEZimmer·cleared 1984-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

Reason for recall

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.