—#169744

Product

Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

FDA product code: FSM — Tray, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868

Why it was recalled

There is a potential for silicone shedding during cleaning and sterilization.

Root cause (FDA determination)

Process control

Action the firm took

Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Timeline

Recall initiated: 2018-11-28
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.