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.
FDA Recall Z-0321-2011 · Posted 2010-11-04
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Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2010-09-07
Date Terminated2010-12-13
Product Quantity396
Reason for Recall
Healing abutment may not fully seat on the implant.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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