—#146044

Product

Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.

FDA product code: HTY — Pin, Fixation, Smooth
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K831005
Affected lot / code info: Part #'s 24415 24416 27914 27922 328010 14-401440 14-450360 14-450365 14-450380 14-450390 35-361681 Lot #'s 679900 693860 729090 722660 668350 591000 591010 591020 652700 745110 752860 728860 652650 664410 664440 606280

Why it was recalled

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Timeline

Recall initiated: 2016-04-01
Posted by FDA: 2016-05-26
Terminated: 2017-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.