—#146038

Product

Various trauma and sports medicine instruments and implants. Plate, fixation, bone.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K093880, K111663
Affected lot / code info: Part #'s 24616 131212112 131212113 131212114 131212116 131212118 131212216 131212218 131212220 131212222 131212224 131212316 131212318 131212320 131212322 856135016 856135018 856135020 856135022 856135024 856135026 856135028 856135030 856135034 856135036 856135038 856135040 856135042 Lot #'s 606160 729130 664900 752650 752660 664910 664930 752680 664950 752690 752720 664990 665020 665040 665060 665070 665090 665100 665120 665130 758430 758500 758520 758540 758550 758570 758670 758680 758700 758710 758720 758730 758740

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 #146038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.