Class 2 Device Recall MDN, ITST, ZNN,

• Date Initiated by Firm: October 10, 2019
• Create Date: November 07, 2019
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-0328-2020
• Recall Event ID: 83962
• 510(K)Number: K142281
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038 00224001040 00224001042 00224001046 00224001048 00224001114 00224001116 00224001118 00224001120 00224001122 00224001124 00224001126 00224001128 00224001130 00224001132 00224001134 00224001136 00224001138 00224001140 00224001142 00224001144 00224001146 00224001214 00224001216 00224001218 00224001220 00224001222 00224001224 00224001226 00224001228 00224001230 00224001232 00224001234 00224001236 00224001238 00224001240 00224001242 00224001244 00224001246 00224001248 00224001314 00224001316 00224001318 00224001320 00224001322 00224001324 00224001326 00224001328 00224001330 00224001332 00224001334 00224001336 00224001338 00224001340 00224001342 00224001344 00224001346 00224001348 00224001414 00224001416 00224001418 00224001424 00224001426 00224001428 00224001430 00224001432 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 00225224008 00225224009 00225224010 00225224012 00225224013 00225226008 00225226009 00225226010 00225226011 00225226012 00225226013 00225228008 00225228009 00225228010 00225228011 00225228012 00225228013 00225228014 00225230008 00225230009 00225230010 00225230011 00225230012 00225230013 00225230014 00225230015 00225230016 00225232008 00225232009 00225232010 00225232011 00225232012 00225232013 00225232014 00225232015 00225232016 00225234008 00225234009 00225234010 00225234011 00225234012 00225234013 00225234014 00225234015 00225234016 00225236008 00225236009 00225236010 00225236011 00225236012 00225236013 00225236014 00225236015 00225236016 00225238008 00225238009 00225238010 00225238011 00225238012 00225238013 00225238014 00225240008 00225240009 00225240010 00225240011 00225240012 00225240013 00225240014 00225240015 00225242008 00225242009 00225242010 00225242011 00225242012 00225242013 00225242014 00225242015 00225242016 00225244008 00225244009 00225244010 00225244011 00225244012 00225244013 00225244014 00225244015 00225244016 00225246009 00225246010 00225246011 00225246012 00225246013 00225246014 00225246016 00225248010 00225248011 00225248012 00225248013 00225248014 00225248015 00225248016 00225250013 00225250014 00225250015 00225250016 00225318006 00225318008 00225318009 00225318011 00225320008 00225320009 00225320010 00225320011 00225320012 00225322006 00225322007 00225322008 00225322009 00225322010 00225322011 00225322012 00225322013 00225324006 00225324007 00225324008 00225324009 00225324010 00225324011 00225324012 00225324013 00225324014 00225326006 00225326007 00225326008 00225326009 00225326010 00225326011 00225326012 00225326013 00225326014 00225326015 00225328007 00225328008 00225328009 00225328010 00225328011 00225328012 00225328013 00225328014 00225328015 00225330006 00225330007 00225330008 00225330009 00225330010 00225330011 00225330012 00225330014 00225330015 00225332006 00225332007 00225332008 00225332009 00225332010 00225332011 00225332012 00225332013 00225332014 00225332015 00225334006 00225334007 00225334008 00225334009 00225334010 00225334011 00225334012 00225334013 00225334014 00225334015 00225336006 00225336007 00225336008 00225336009 00225336010 00225336011 00225336012 00225336013 00225336014 00225336015 00225338006 00225338007 00225338008 00225338009 00225338010 00225338011 00225338012 00225338013 00225338014 00225338015 00225340007 00225340008 002253400
• 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 = HSB