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Product 11 consists of all product under product code JDI recallZ-1109-2016 · Zimmer Manufacturing B.V. · initiated Jan 11, 2016

Class II Terminated All recalls posted in March 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging

What the company is doing

Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Recall details

Recall number
Z-1109-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 11, 2016
Posted by the FDA
Mar 12, 2016
Recalling firm
Zimmer Manufacturing B.V.
Quantity
366
Product code
JDI
FDA submissions
K960278
Distribution
US Nationwide Distribution

Product description

Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603000 6 DEGREE COCR FEM HEAD 28 902603300 6 DEGREE COCR FEM HEAD 32 902603200 6 DEGREE COCR FEM HEAD 32 Product Usage: For use in total or hemi hip arthroplasty

Code information (models, lots, serial numbers)

lot no:61603870 60973105N 60892289N 60900891N 62279763 62093449 62185961 62279764 62384218 62082438 62268537 62384219

Other devices under the same FDA submission

1 device cleared under K960278 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 72900).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page