{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161178", "product_res_number": "Z-0722-2018", "event_date_initiated": "2017-08-01", "event_date_created": "2018-02-26", "recall_status": "Terminated", "event_date_terminated": "2020-03-18", "res_event_number": "78762", "product_code": "LPH", "k_numbers": [ "K953337", "K973714" ], "product_description": "Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: \na. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); \nb. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); \nc. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); \nd. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); \ne. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); \nf. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); \ng. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); \nh. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); \ni. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); \nj. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); \nk. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); \nl. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); \nm. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); \nn. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); \no. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); \np. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); \nq. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); \nr. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); \ns. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); \nt. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756\nu. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); \nv. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); \nw. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); \nx. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); \ny. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); \nz. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); \naa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); \nab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); \nac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); \nad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); \nae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256)\n \nComponents of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.", "code_info": "a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025);  b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025);  c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026);  d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026);  e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026);  f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025);  g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026);  h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026);  i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026);  j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026);  k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026);  l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026);  m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026);  n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025);  o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025);  p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026);  q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026);  r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025);  s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026);  t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025):  u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026);  v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026);  w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026);  x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026);  y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025);  z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026);  aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026);  ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026);  ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026);  ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026);  ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "574-267-6131", "reason_for_recall": "The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.", "root_cause_description": "Package design/selection", "action": "The firm, Zimmer Biomet, sent an \"URGENT MEDICAL DEVICE RECALL REMOVAL\"-Lot Specific letter dated 8/1/2017 to its Customers via email and/or FedEx. The letter describes the product, problem and actions to be taken. The Instructions to Distributors, Sales Representatives, and Distributor Operation Managers included to ensure affected team member are aware of the contents of the notification letter, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., return all affected product, and note if there are any hospitals and/or surgeons for which need to be notified. \n\nInstructions for Risk Managers and surgeons are to ensure affected personnel are aware of the contents of the notification letter, quarantine any affected product on hand, complete and return the Certificate of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., and return any affected product on hand. \n\nFor questions or concerns, please call the 411 call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday or email corporatequality.postmarket@zimmerbiomet.com", "product_quantity": "38,069 units total", "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.", "openfda": { "k_number": [ "K963309", "K101761", "K251833", "K970300", "K953694", "K971020", "K103384", "K163193", "K010170", "K002960", "K132572", "K042252", "K852198", "K200656", "K200391", "K172684", "K974506", "K041109", "K102399", "K964769", "K072154", "K041950", "K100933", "K220468", "K010282", "K935875", "K953664", "K192450", "K070278", "K953490", "K000538", 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