Devices

Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).

Model / Serial
Lot Numbers: 081009-01, 081009-02, 081009-03, 081023-01, 081023-02, 081106-01, 081106-02, 081106-03, 081113-01, 081113-02, 081113-03, 081113-04, 081113-05, 081118-01 and 081118-02.
Product Classification
Orthopedic Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide Distribution -- states of VA, WI, and CO.
Product Description
Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. || The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. || by the attending physician.
Manufacturer
Theragenics Corporation
1 Event
- Recall of Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).

Manufacturer

Theragenics Corporation

Manufacturer Address
Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518
Manufacturer Parent Company (2017)
Juniper Holdings Inc.
Source
USFDA

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