Z-2799-2011

"REF IWTH56Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).* Healing abutment* STERILE.***Rx...

Name: Z-2799-2011 "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx...
Creator: Biomet 3i, LLC
Published: 2010-02-23
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2010-02-23 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc... on 2010-02-23. The reason FDA records is "Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2799-2011
Status: Terminated
Initiated: 2010-02-23
Posted: 2011-07-13
Terminated: 2011-11-09
Recalling firm: ZimVie US Corp LLC
Product: "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
Product code: NSQ Restoration, Base Metal
Reason for recall: Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, BIOMET 3i, initially contacted each US customer by telephone using a prepared phone script. Following telephone contact, the firm followed up each call with a faxed "Urgent: Medical Device Recall" letter dated March 1, 2010. International customers were notified first by email then by fax. The letter and email described the product, problem and actions to be taken. The customers were instructed to return the healing abutment(s) for replacement if they have not already opened and used the product; respond with the attached response fax and return the product(s) to the: Regulatory Affairs Department, BIOMET 3i, 4555 Riverside Drive, Palm Beach Gardens, FL 33410, Incident No. IC95863. BIOMET will send a replacement healing abutment(s) once the returned product is received. If you have any questions or concerns, please contact the Recall Coordinator at 561-776-6906.
Quantity in commerce: 49
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Europe and Japan.
Product codes and lots: Lot number: 6022691.

Product code NSQ

K934126Class IIOne and Two Piece Temporary Healing,(emergence Profile) AbutmentsImplant Innovations, Inc. / cleared 1994-04-25

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)