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U.S. Department of Health and Human Services

Class 2 Device Recall FITMORE HIP STEM

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  Class 2 Device Recall FITMORE HIP STEM 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-0320-2020
Recall Event ID 83962
510(K)Number K071723  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102
0100551103
0100551104
0100551105
0100551106
0100551107
0100551108
0100551109
0100551110
0100551111
0100551112
0100551113
0100551114
0100551201
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0100551206
0100551207
0100551208
0100551209
0100551210
0100551211
0100551212
0100551213
0100551214
0100551301
0100551302
0100551303
0100551304
0100551305
0100551306
0100551307
0100551308
0100551309
0100551310
0100551311
0100551312
0100551313
0100551314
0100551401
0100551402
0100551403
0100551404
0100551405
0100551406
0100551407
0100551408
0100551409
0100551410
0100551411
0100551412
0100551413
0100551414
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 = LZO and Original Applicant = ZIMMER GMBH
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