Z-0753-2013Class II

TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal...

Name: Z-0753-2013 TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal...
Creator: Biomet, Inc.
Published: 2013-01-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-01-03 / Terminated

FDA source

Biomet, Inc. began a recall of TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and... on 2013-01-03. FDA classified it as Class II and gives the reason as "Thru hole at the tip of the screw is undersized". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0753-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-03
Posted: 2013-01-30
Terminated: 2013-08-02
Recalling firm: Zimmer GmbH
Product: TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Thru hole at the tip of the screw is undersized.
FDA root cause: Reprocessing Controls
Action: Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated January 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed locate and discontinue use of the affected product and return it to Biomet. recall notification was sent to all consignees on 1/4/2013. The action requires the immediate location and discontinued use of the product and its return to Biomet. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
Quantity in commerce: 44 units distributed
Distribution: Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
Product codes and lots: Catalog Number: 909668 Lot Number Identification: 716710

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-30

Product code HWC

K934469Class IIArthrotek Interference ScrewBiomet, Inc. / cleared 1994-02-23

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)