Z-2227-2009

3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile...

Name: Z-2227-2009 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile...
Creator: Biomet 3i, LLC
Published: 2006-12-11
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2006-12-11 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive... on 2006-12-11. The reason FDA records is "Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating". 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-2227-2009
Status: Terminated
Initiated: 2006-12-11
Posted: 2009-09-22
Terminated: 2009-10-01
Recalling firm: ZimVie US Corp LLC
Product: 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.
Product code: NDA Helmet, Cranial, For Protective Use
Reason for recall: Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.
Quantity in commerce: 24
Distribution: USA and Italy
Product codes and lots: Lot # 51298

Product code NDA

K072642Class IIBiomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. / cleared 2007-12-20

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)