—#206937

Product

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K031061
Affected lot / code info: Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, 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(01)00889024207806(17)331107(10)66324859, (01)00889024207790(17)331111(10)66324849, (01)00889024207790(17)331126(10)66324846, (01)00889024207806(17)331127(10)66324856, (01)00889024207790(17)331201(10)66324852, (01)00889024207806(17)331203(10)66324862, (01)00889024207790(17)331208(10)66378806, (01)00889024207790(17)331212(10)66364015, (01)00889024207820(17)340110(10)66378834, (01)00889024207806(17)340113(10)66364020; Lot Code: 64115713, 64175075, 64175076, 64175073, 64138317, 64175074, 64194991, 64202116, 64178998, 64179054, 64202117, 64179043, 64194989, 64178996, 64178997, 64179023, 64178999, 64179043R, 64194989R, 64202115, 64226003, 64226007, 64226008, 64220651, 64226001, 64226006, 64202119, 64226002, 64202118, 64254389, 64254390, 64226077, 64226078, 64226009, 64226076, 64254387, 64254388, 64261032, 64226129, 64242244, 64254386, 64226076R, 64254386R, 64254387R, 64261030, 64275592, 64275434, 64261033, 64261035, 64261031, 64275593, 64261029, 64275538, 64275540, 64261037, 64261036, 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Why it was recalled

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

Root cause (FDA determination)

Process change control

Action the firm took

Consignees were sent an URGENT MEDICAL DEVICE RECALL notification dated 3/28/24. Distributors are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory, return all affected product from the respective distributorship and affected hospitals to Zimmer by submitting an Inventory Return Certification Form to CorporateQuality.PostMarket@zimmerbiomet.com (international returns are to be coordinated by emailing zimmerbiometintlirarequests@zimmerbiomet.com), and retain a copy of the Inventory Return Certification and product returns forms. Risk Managers are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory with the assistance of a Zimmer Biomet sales representative, the Zimmer Biomet sales representative will remove affected devices from consignee facilities, return the provided Certificate of Acknowledgement to CorporateQuality.PostMarket@zimmerbiomet.com, and retain a copy of the acknowledgement form for your records. Surgeons are to review the provided notification, complete the provided Certificate of Acknowledgement to CorporateQuality.PostMarket@zimmerbiomet.com, retain a copy of the acknowledgement form for your records; there is no specific patient monitoring instructions related to this recall. Consignees with any questions are to contact Customer Service at 574-371-3071 from Monday through Friday between the hours of 8:00 am and 5:00 pm EST.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.

Timeline

Recall initiated: 2024-03-28
Posted by FDA: 2024-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.