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

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.

Orthopedic Devices

3

Yes

Nationwide Distribution -- states of VA, WI, and CO.

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.