Z-0593-2016Class II

BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655...

Name: Z-0593-2016 BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655...
Creator: Biomet 3i, LLC
Published: 2015-09-21
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2015-09-21 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are... on 2015-09-21. FDA classified it as Class II and gives the reason as "Inadequate biocompatibility testing". 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-0593-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Posted: 2016-01-06
Terminated: 2016-10-12
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Inadequate biocompatibility testing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Biomet 3i, sent an "URGENT DEVICE RECALL NOTICE" letter dated September 16, 2015 to both Domestic and Foreign Customers via traceable courier. The letter described the product, problem and actions to be taken. The customers were instructed to review the notice and check your inventory for the affected units; immediately quarantine and remove all affected products from service; if you have product to return, call Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700 to obtain a CMP# and return affected product to Biomet 3i Returns, 4555 Riverside Dr., Palm Beach Gardens, FL 34410; complete and return the attached Business Reply Form via fax to: +1-561-514-6316 or email to: [email protected], and maintain a copy of the notice for your records. For assistance or any other questions that you may have, please contact Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700. The Complaints Department is available 8:00am to 6:00pm (Eastern), Monday through Friday.
Quantity in commerce: 30,111 devices.
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
Product codes and lots: Model Number: PIC484, Lot Numbers: 942680, 950198, 950706, 957203, 963249, 973436, 977567, 993384, 1004520, 1015298, 1024240, 1034518, 1048991, 1057119, 1095480, 1105770, 1131300, 1133485, 1158650, 1165796, 1169295, 1172741, 1175519, 1178568, 1181589, 1184490; Model Number: PIC484H, Lot Numbers: 952664, 1023220, 1034517, 1057121, 1084058, 1085156, 1086404, 1115750, 1169297, 1174217, 1182906, 1187568; Model Number: PIC485, Lot Numbers: 1137568, 1137603, 1176653, 1184855; Model Number: PIC485H, Lot Numbers: 1113005, 1170171, 1181580; Model Number: PIC654, Lot Numbers: 934480, 950196, 954781, 957204, 961452, 977568, 988996, 1016258, 1024427, 1034516, 048990, 1060550, 1073328, 1073329, 1092256, 1105771, 1115811, 1115812, 1115813, 1115815, 1115816, 1116774; Model Number: PIC654H, Lot Numbers: 970700, 988995, 989022, 1015301, 1043973, 1069114, 1073325, 1073327, 1074848, 1147383, 1166591, 1174216, 1184508, 1184509; Model Number: PIC655, Lot Numbers: 1040760, 1044047, 1048195, 1115778; Model Number: PIC655H, Lot Numbers: 1031581, 1079916, 973403-S1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0593-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0591-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-05
Z-0592-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-05
Z-0593-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-05
Z-0594-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-05

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)