—#161802

Product

fastener, fixation, nondegradable, soft tissue

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K143037
Affected lot / code info: Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

Why it was recalled

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Root cause (FDA determination)

Process control

Action the firm took

In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.

Recalling firm

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

Distribution

Distribution pattern: TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

Timeline

Recall initiated: 2017-10-25
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161802. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.