Recall Z-1124-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1124-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-01-11, terminated 2017-04-13. It names one FDA 510(k) clearance: K892800. Product: Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: For use in total or hemi hip arthroplasty. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Terminated: 2017-04-13
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K892800 — MG II POROUS TOTAL KNEE SYSTEMZimmer, Inc.·cleared 1989-08-03

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

Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: For use in total or hemi hip arthroplasty

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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