Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fr

FDA device recall Z-1236-2018 · posted 2018-03-27 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

Action taken

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" notice dated 3/12/2018 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: Risk Manager: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative and quarantine all affected product. 3. Zimmer Biomet sales representative will remove the affected product from the facility. 4. Complete Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. Distributors: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Locate and quarantine affected product in your inventory. 3. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory. Mark RECALL on the outside of the returned cartons. 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com EXPANSION: The firm expanded the recall to include additional lots and the new notification sent 3/23/18, also explains the additional issue that devices were etched with a supplier lot number and the packages were etched with the firm lot number. Both numbers are included in an Appendix to the notification letter.

Root cause

Device Design

Status

Terminated

Product code

HSB

Quantity affected

2470

Distribution

Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto R

Date initiated

2018-03-12

Date posted

2018-03-27

Date terminated

2019-11-18

Location

Warsaw, IN

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