Recall Z-1683-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1683-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-04

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-05-04, terminated 2017-07-05. It names one FDA 510(k) clearance: K840643. Product: Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560. Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Terminated: 2017-07-05
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K840643 — HARRIS-GALANTE POROUS TOTAL HIP SYSZimmer, Inc.·cleared 1984-04-17

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

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

Reason for recall

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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