—#143636

Product

HipLOC CHS Plate/Lag Screw Introducer

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

Why it was recalled

A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

Root cause (FDA determination)

Process change control

Action the firm took

Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. You do not need to complete the Biomet UK response form. Use priority carrier for your shipment. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: "Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or "Call (800)FDA-1088 Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. 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: US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.

Timeline

Recall initiated: 2016-02-16
Posted by FDA: 2016-02-25
Terminated: 2017-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.