Recalls / —
—#162975
Product
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Numbers: 63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
Why it was recalled
Potential failure of sterile packaging seal.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Timeline
- Recall initiated
- 2018-03-26
- Terminated
- 2020-11-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.