Skip to content

Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty.… recallZ-2135-2011 · Biomet, Inc. · initiated Mar 10, 2011

Terminated All recalls posted in May 2011

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 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 30 mm screws was switched with one lot of 25 mm screws.

FDA root cause category: Mixed-up of materials/components

What the company is doing

Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet. Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product. Distributors were instructed to notify all sub-accounts of the recall. Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983. For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.

Recall details

Recall number
Z-2135-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 10, 2011
Posted by the FDA
May 3, 2011
Recalling firm
Biomet, Inc.
Quantity
100
Product code
HWD
FDA submissions
K991807
Distribution
Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.

Product description

Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

Code information (models, lots, serial numbers)

Part: 103532, Lot: 427460; and Part: 103533, Lot: 502360.

Other devices under the same FDA submission

17 devices cleared under K991807 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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