Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 AST

FDA device recall Z-1113-2016 · posted 2016-03-12 · Terminated

Recall details

Recalling firm

Zimmer Manufacturing B.V.

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.

Action taken

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 corporatequality.postmarket@zimmerbiomet.com. 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.

Root cause

Packaging

Status

Terminated

Product code

JDI

Quantity affected

0

Distribution

US Nationwide Distribution

Date initiated

2016-01-11

Date posted

2016-03-12

Date terminated

2017-04-13

Location

Mercedita, PR