Recall Z-1158-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1158-2016
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: K965098. Product: Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.. 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

K965098 — INTRAMEDULLARY NAIL SYSTEMZimmer, Inc.·cleared 1997-02-28

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 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

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.