"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Mad
FDA device recall Z-2799-2011 · posted 2011-07-13 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- NSQ
- Quantity affected
- 49
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, Europe and Japan.
- Date initiated
- 2010-02-23
- Date posted
- 2011-07-13
- Date terminated
- 2011-11-09
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS (K934126) | Implant Innovations, Inc. | 1994-04-25 |