• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Maxera, Moore, Thompson, Versys, Trilogy, TM Modular Acetabular System, Anatomic Hip Stem, M/L Taper

  • 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 Maxera, Moore, Thompson, Versys, Trilogy, TM Modular Acetabular System, Anatomic Hip Stem, M/L Taper see related information
Date Initiated by Firm October 10, 2019
Create Date November 07, 2019
Recall Status1 Terminated 3 on May 19, 2020
Recall Number Z-0318-2020
Recall Event ID 83962
510(K)Number K973124  K181630  K171858  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code LPH
Product Various Hip Joint Replacement Systems, Item Nos. 00151504232
00151504432
00151504636
00151504836
00151505040
00151505240
00151505444
00151505644
00151505848
00151506048
00151506248
00151506448
00151506648
00400500060
00401000038
00401000040
00401000041
00401000042
00401000043
00401000044
00401000045
00401000046
00401000047
00401000048
00401000049
00401000050
00401000051
00401000052
00401000053
00401000054
00401000055
00402100857
00402100863
00402101243
00402101244
00402200040
00402200042
00402200051
00402200057
00408801106
00408801206
00408801226
00408801236
00408801306
00408801326
00408801336
00408801356
00408801376
00408801406
00408801426
00408801436
00408801456
00408801476
00408801506
00408801526
00408801536
00408801556
00408801576
00408801606
00408801626
00408801636
00408801656
00408801706
00408801806
00455500700
00455501001
00455502000
00455502001
00455503000
00455503001
00455504001
00500103800
00500103900
00500104000
00500104100
00500104200
00500104300
00500104400
00500104500
00500104600
00500104700
00500104800
00500104900
00500105000
00500105100
00500105200
00500105300
00500105400
00500105500
00500105700
00500105800
00500106000
00500106200
00500106400
00500106600
00500106800
00500107000
00620003620
00620003820
00620004020
00620004021
00620004023
00620004220
00620004221
00620004223
00620004420
00620004421
00620004423
00620004424
00620004620
00620004621
00620004623
00620004820
00620004821
00620004822
00620004823
00620005020
00620005021
00620005022
00620005023
00620005220
00620005221
00620005222
00620005223
00620005420
00620005421
00620005422
00620005423
00620005424
00620005620
00620005621
00620005622
00620005623
00620005624
00620005820
00620005821
00620005822
00620005823
00620005824
00620006020
00620006021
00620006022
00620006023
00620006220
00620006221
00620006222
00620006223
00620006224
00620006420
00620006421
00620006422
00620006423
00620006620
00620006621
00620006622
00620006623
00620006624
00620006820
00620006821
00620006822
00620006823
00620006824
00620007020
00620007021
00620007022
00620007023
00620007220
00620007620
00620008020
00620104800
00620105000
00620105200
00620105400
00620105600
00620105800
00620106000
00620106200
00620106400
00620106600
00620107000
00620203820
00620203822
00620204020
00620204022
00620204220
00620204222
00620204420
00620204422
00620204620
00620204622
00620204820
00620204821
00620204822
00620205020
00620205021
00620205022
00620205220
00620205221
00620205222
00620205420
00620205421
00620205422
00620205620
00620205621
00620205622
00620205820
00620205821
00620205822
00620206020
00620206022
00620206220
00620206222
00620206420
00620206422
00620206620
00620206622
00620206820
00620206822
00620207020
00620207022
00620207220
00620207420
00620207620
00620208020
00633410132
00640004822
00640005020
00640005022
00640005222
00640005420
00640005422
00640005620
00640005622
00640005822
00640006022
00640006220
00640006222
00640006420
00640006422
00640006620
00640006622
00640006820
00640006822
00640007020
00640007022
00671000301
00671000302
00671000401
00671000402
00671000501
00671000502
00671000601
00671000602
00671000701
00671000702
00671000801
00671000802
00671000901
00671000902
00672000102
00672000111
00672000112
00672000201
00672000202
00672000211
00672000212
00672000311
00672000411
00672000412
00672000501
00672000502
00672000512
00672000601
00672000602
00672000611
00672000612
00763301100
00763301200
00763301300
00763301400
00763401000
00763401100
00763401200
00763401300
00763401400
00763401500
00763401600
00765301101
00765301140
00765301201
00765301240
00765301301
00765301340
00765301401
00765301440
00765301501
00765301540
00765301601
00765401100
00765401400
00771100410
00771100440
00771100500
00771100510
Code Information All product 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 2
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 = LPH and Original Applicant = New Standard Device DBA Metalogix
510(K)s with Product Code = LPH and Original Applicant = SULZER ORTHOPEDICS, INC.
510(K)s with Product Code = LPH and Original Applicant = Zimmer GmbH
-
-