Recalls / —

—#162979

Product

Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lot Numbers:  63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537

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 #162979. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.