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U.S. Department of Health and Human Services

Class 2 Device Recall Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.

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  Class 2 Device Recall Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. see related information
Date Initiated by Firm August 01, 2017
Create Date February 26, 2018
Recall Status1 Open3, Classified
Recall Number Z-0722-2018
Recall Event ID 78762
510(K)Number K953337  K973714  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows:
a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906);
b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106);
c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206);
d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936);
e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036);
f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136);
g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236);
h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406);
i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506);
j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606);
k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706);
l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806);
m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826);
n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926);
o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006);
p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026);
q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126);
r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226);
s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746);
t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756
u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836);
v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846);
w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856);
x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946);
y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956);
z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046);
aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056);
ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146);
ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156);
ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246);
ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256)

Components 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 Information 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)
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
574-267-6131
Manufacturer 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.
FDA Determined
Cause 2
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. Instructions 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. For 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
Quantity in Commerce 38,069 units total
Distribution 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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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