Z-2135-2011

Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box...

Name: Z-2135-2011 Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box...
Creator: Biomet, Inc.
Published: 2011-03-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-03-10 / Terminated

FDA source

Biomet, Inc. began a recall of 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... on 2011-03-10. The reason FDA records is "One lot of 30 mm screws was switched with one lot of 25 mm screws". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2135-2011
Status: Terminated
Initiated: 2011-03-10
Posted: 2011-05-03
Terminated: 2012-02-17
Recalling firm: Zimmer GmbH
Product: 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.
Product code: HWD Starter, Bone Screw
Reason for recall: One lot of 30 mm screws was switched with one lot of 25 mm screws.
FDA root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 100
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 codes and lots: Part: 103532, Lot: 427460; and Part: 103533, Lot: 502360.

Product code HWD

K991807Class IITitanium Low Profile ScrewsBiomet, Inc. / cleared 1999-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)