FDA Medical Device Recalls (openFDA)
BioHorizons Implant Systems Inc: Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.
- Recall number
- Z-0321-2011
- Recalling firm
- BioHorizons Implant Systems Inc
- Product
- Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.
- Status
- Terminated
- Initiated
- 2010-09-07
- Posted
- 2010-11-04
- Terminated
- 2010-12-13
- Reason
- Healing abutment may not fully seat on the implant.
- Root cause
- Other
- Action
- Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.
- Quantity
- 396
- Distribution
- Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
- Lot, serial or model codes
- Lot #0903233
- 510(k) numbers
- ["K053152"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000592496
- Firm city
- Birmingham
- Firm state
- AL
- 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