Z-1615-2011

STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive...

Name: Z-1615-2011 STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive...
Creator: Biomet, Inc.
Published: 2011-01-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-01-21 / Terminated

FDA source

Biomet, Inc. began a recall of STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot... on 2011-01-21. The reason FDA records is "The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1615-2011
Status: Terminated
Initiated: 2011-01-21
Posted: 2011-03-09
Terminated: 2011-11-10
Recalling firm: Zimmer GmbH
Product: STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
FDA root cause: Pending
Action: The firm sent URGENT MEDICAL DEVICE RECALL NOTICES dated 1/21/2011 to distributors, implanting physicians, and medical facilities. The letter to the distributors and medical facilities states the recalled product should be immediately located and returned to Biomet. In addition, the "FAX Back Response Form" should be completed and returned to the number provided. If product has been further distributed, distributors are to contact hospital personnel via the enclosed "Dear Biomet Customer" notice. The letter to the implanting physicians informs the physician of the recall and lists the patients that were implanted with the device. The physician letter quotes from the surgical technique "the implant should also be removed if any postoperative complications occur". The letter to the implanting physicians does not recommend any action be taken with the devices that are implanted. The notice just makes the surgeons aware of the recall. Distributors and Physicians are to confirm receipt of the letter by contacting 800-348-9500, ext 3755 or 3756. Also, questions related to this matter should be directed to 574-371-3755 or 574-371-3756.
Quantity in commerce: 254 all products
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 384950, 879290, and 890870.

Product code HWC

K071498Class IISubtalar ImplantBiomet Sports Medicine, Inc. / cleared 2007-07-31

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)