Skip to content

LOCK SCREW SQUARE DRIVE recallZ-0708-2019 · Zimmer Biomet, Inc. · initiated Nov 20, 2018

Terminated

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 Biomet, Inc. 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

One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws

FDA root cause category: Packaging process control

What the company is doing

Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Recall details

Recall number
Z-0708-2019
Status
Terminated
Initiated by the company
Nov 20, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
50 pieces
Product code
LXT
FDA submissions
K112345
Distribution
Country of Japan

Product description

Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

Code information (models, lots, serial numbers)

LOT 029980 UDI (01)00880304535589(17)280501(10)029980

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 81704).

Sources and updates

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