—#165711

Product

Connecting Bolt, Model 14-442093

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: ...

Why it was recalled

Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.

Root cause (FDA determination)

Employee error

Action the firm took

Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Risk Manager were advised to take the following actions: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete and return the Certificate of Acknowledgement form via email to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing the notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Distributors are encouraged to do the following: Review th notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number through Fast SMS or by emailing rgarequest@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for

Recalling firm

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

Distribution

Distribution pattern: AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI

Timeline

Recall initiated: 2018-06-18
Terminated: 2020-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.