Z-2229-2010

SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw...

Name: Z-2229-2010 SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw...
Creator: Biomet, Inc.
Published: 2010-06-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-06-18 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010. Used to... on 2010-06-18. The reason FDA records is "The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2229-2010
Status: Terminated
Initiated: 2010-06-18
Posted: 2010-08-16
Terminated: 2012-08-06
Recalling firm: Zimmer GmbH
Product: SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010. Used to pass suture through tissue.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.
Quantity in commerce: 301 units total
Distribution: Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands.
Product codes and lots: Lot numbers: 050260, 863960, and 863970.

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)