Class 2 Device Recall Freelock, Versa FX, Versa FX II, Cables, ZNN,

• Date Initiated by Firm: October 10, 2019
• Create Date: November 07, 2019
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-0326-2020
• Recall Event ID: 83962
• 510(K)Number: K090596 K150818 K830196
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 00118101547 00118101552 00118101557 00118109006 00118109008 00118109010 00118109506 00118109510 00118113002 00118113003 00118113004 00118113005 00118113006 00118113008 00118113010 00118113012 00118113094 00118113502 00118113503 00118113504 00118113505 00118113506 00118113508 00118113510 00118113512 00118113514 00118113594 00118113595 00118114002 00118114003 00118114004 00118114005 00118114006 00118114008 00118114010 00118114012 00118114014 00118114094 00118114095 00118114502 00118114503 00118114504 00118114505 00118114506 00118114508 00118114510 00118114512 00118114514 00118114594 00118114595 00118115002 00118115003 00118115004 00118115005 00118115006 00118115008 00118115010 00118115012 00118115094 00119300520 00119300522 00119300525 00119300537 00119301020 00119301022 00119301025 00119301027 00119301030 00119301032 00119301035 00119301037 00119301040 00119301042 00119301045 00119301047 00119301050 00119301052 00119301057 00119301070 00119301520 00119301522 00119301525 00119301530 00119301532 00119301535 00119301537 00119301540 00119301542 00119301545 00119301547 00119301550 00119301552 00119301555 00119301557 00119301560 00119301562 00119301567 00119309008 00119309010 00119309012 00119309014 00119309506 00119309508 00119309510 00119309512 00119309514 00119309516 00119309522 00119313002 00119313003 00119313004 00119313005 00119313006 00119313008 00119313010 00119313012 00119313016 00119313094 00119313095 00119313096 00119313502 00119313503 00119313504 00119313505 00119313506 00119313508 00119313510 00119313512 00119313514 00119313516 00119313594 00119313595 00119313596 00119314002 00119314003 00119314004 00119314005 00119314006 00119314008 00119314010 00119314012 00119314018 00119314094 00119314095 00119314096 00119314502 00119314503 00119314504 00119314505 00119314506 00119314508 00119314510 00119314512 00119314514 00119314516 00119314520 00119314594 00119314595 00119314596 00119315003 00119315004 00119315005 00119315006 00119315008 00119315010 00119315012 00119315014 00119315016 00119315018 00119315020 00119315094 00119315095 00119315096 00119413004 00119413005 00119413006 00119413008 00119413504 00119413505 00119413506 00119413508 00119413594 00119413595 00119413596 00119414004 00119414005 00119414006 00119414008 00119414504 00119414505 00119414506 00119414508 00119415004 00119415005 00119415006 00119415008 00223200118 00223200128 00223200228 00223200301 00223200302 00223200303 00223200318 00223200418 00223200518 00223201113 00223202113 00223205018 00223205019 00223205020 00223205021 47223206000 47223206035 47223206055 47249134015 47249136015 47249140015 47249142015 47249144015 47249146015 47249148009 47249148010 47249148011 47249148012 47249148013 47249148014 47249148015 47249248009 47249248010 47249248011 47249248012 47249248013 47249248014 47249248109 47249248110 47249248111 47249248112 47249248113 47249248114 47349134009 47349134010 47349134011 47349134012 47349134013 47349134014 47349134015 47349136009 47349136010 47349136011 47349136012 47349136013 47349136014 47349136015 47349138009 47349138010 47349138011 47349138012 47349138013 47349138014 47349138015 47349140009 47349140010 47349140011 47349140012 47349140013 47349140014 47349140015 47349142009 47349142010 473491420
• Code Information: All products manufactured prior to January 2014.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Zimmer Biomet Customer Service; 574-371-3071
• Manufacturer Reason for Recall: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
• FDA Determined Cause: Packaging change control
• Action: The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's 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.
• Quantity in Commerce: 5,459,583 total devices
• Distribution: Distributed nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KTT