Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Reverse Shoulder Instrument Case

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Comprehensive Reverse Shoulder Instrument Case see related information
Date Initiated by Firm June 10, 2019
Create Date July 12, 2019
Recall Status1 Terminated 3 on September 10, 2020
Recall Number Z-1961-2019
Recall Event ID 83099
Product Classification Tray, surgical, instrument - Product Code FSM
Product Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Code Information Lots: 251059  254986  203752 260646 263012 264753 2111048 2111052 2111050 2111051 21110107 21110106 21110117 2291017 2881019 3231032 2981046 3341019  831129 1961120  21110105  21110108  1961120  1961120  1961120  3461146  1961120  1961120  1961120  1961120  1961120  3461146  1081211  1081211  1081211  1951228  1951228  1951228  1951228  1951228  3181203  3181203  3181203  3181203  1411303  1411303¿ 1411303  1721312  1721312  1721312  2631353  2631353  3461146  MB33730  171421 1721312  ME50120  ME50130  1641404  MH50820  1641404  1641404  2331407  1721312  1961120  2291016  3461146  2331407  2331407  ML35700  2331407  2631048  ML56520  2331407  2331407  2331407  2331407  961509  961509 961509  961509  MO93600  MO93610  961509  961509  1631512  1631512  2261523  2261523  2261523  2681520  2681520  2681520  443894  2681520  443894  443894  476977  476977  501920  501920  530934  538816  
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Lack of an adequate sterilization validation.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medical Device Recall notification letters dated 6/10/19 were sent to customers.
Quantity in Commerce 1257
Distribution The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
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.
-
-