FDA Device recall Z-0562-2013

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244

FDA Device
Class II
terminated
Published 2012-12-26

On 2012-12-26 the FDA classified a Class II recall of Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244 by Biohorizons Implant Systems, citing the cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0562-2013
Classification	Class II
Status	terminated
Initiated	2012-11-19
Published	2012-12-26
Last updated	2026-09-13 11:53 UTC
Company	Biohorizons Implant Systems
Distribution	US

Product

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Reason

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Identifiers

code_info	Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707… Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107

code_info

Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707…

Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Biohorizons Implant Systems

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Device · Class II · 2015-12-16 · Biohorizons Implant Systems
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant…
FDA Device · Class II · 2015-05-20 · Biohorizons Implant Systems
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 3…
FDA Device · Class II · 2014-02-26 · Biohorizons Implant Systems
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
FDA Device · Class II · 2012-12-26 · Biohorizons Implant Systems

All Biohorizons Implant Systems recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0562-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.