FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
- Recall number
- Z-2838-2011
- Recalling firm
- Biomet 3i, LLC
- Product
- "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
- Status
- Terminated
- Initiated
- 2010-12-01
- Posted
- 2011-07-16
- Terminated
- 2011-07-18
- Reason
- On December 1, 2010 Biomet 3i recalled their product Incise Zirconia Coping (CBZR0102). The Coping contains a manufacturing defect. Coping is oversized. All affected direct accounts were notified by letter on December 14, 2010.
- Root cause
- Nonconforming Material/Component
- Action
- Biomet 3i sent an "MEDICAL DEVICE RECALL" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product. Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906.
- Quantity
- 16
- Distribution
- Worldwide Distribution--USA (nationwide) and the country of Canada.
- Lot, serial or model codes
- Lot numbers: 97646, 97415, 97418, 97422, 97417 97421, 97420, 97481, 97423, 97419, 97488, 97476, 97478, 97486 97490, 97416.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSP
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28