Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

FDA device recall Z-2744-2015 · posted 2015-09-09 · Terminated

Recall details

Recalling firm

Biomet Spine, LLC

Reason for recall

Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

Action taken

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page two of this notice. " Carefully follow the instructions on the enclosed "Response Form". " If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone: Online: Fax: Phone: Regular Mail: www. fda .gov /MedWatch/report.htm (800) FDA-0178 (800} FDA-1088 Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST. Zimmer Blomet

Root cause

Labeling mix-ups

Status

Terminated

Product code

KWQ

Quantity affected

7 parts

Distribution

Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

Date initiated

2015-08-05

Date posted

2015-09-09

Date terminated

2016-02-10

Location

Broomfield, CO

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