Z-2312-2009

Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 The screw devices...

Name: Z-2312-2009 Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 The screw devices...
Creator: Ebi, L.p.
Published: 2009-04-02
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2009-04-02 / Terminated / root cause: manufacturing process

FDA source

EBI, L.P. began a recall of Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in... on 2009-04-02. The reason FDA records is "Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2312-2009
Status: Terminated
Initiated: 2009-04-02
Posted: 2009-09-22
Terminated: 2009-09-23
Recalling firm: Ebi, LLC
Product: Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
Quantity in commerce: 1
Distribution: Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
Product codes and lots: Catalog Number 6588, Packaging Lot: 651150, Unpackaged lot 605119

Product code KWP

K993956Class IITitanium Pediatric Femoral NailBiomet, Inc. / cleared 1999-12-20

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)