Zimmer Inc. Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 050433, BP050199, BP050258 and BP050350.
Products Sold
Lots 050433, BP050199, BP050258 and BP050350.
Zimmer Inc. is recalling Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 11 due to Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.
Recommended Action
Per FDA guidance
Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026