| Class 2 Device Recall Freelock, Versa FX, Versa FX II, Cables, ZNN, | |
Date Initiated by Firm | October 10, 2019 |
Create Date | November 07, 2019 |
Recall Status1 |
Terminated 3 on May 19, 2020 |
Recall Number | Z-0326-2020 |
Recall Event ID |
83962 |
510(K)Number | K090596 K150818 K830196 |
Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
|
Product | Various fixation systems and accessories, Item Nos. 00118100522
00118100527
00118100530
00118100532
00118100535
00118100537
00118100540
00118100542
00118100550
00118100552
00118100562
00118100565
00118100567
00118101022
00118101025
00118101027
00118101030
00118101032
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00118101037
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00118101042
00118101045
00118101047
00118101050
00118101052
00118101055
00118101057
00118101060
00118101522
00118101525
00118101527
00118101530
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00118114003
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00118114012
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00118114094
00118114095
00118114502
00118114503
00118114504
00118114505
00118114506
00118114508
00118114510
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00118114514
00118114594
00118114595
00118115002
00118115003
00118115004
00118115005
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00118115008
00118115010
00118115012
00118115094
00119300520
00119300522
00119300525
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00119301022
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00119301032
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00119301047
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00119301057
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00119301557
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00119309008
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00119313003
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00119313005
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00119313008
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00119313012
00119313016
00119313094
00119313095
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00119314008
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00119314596
00119315003
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00119315005
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00119315010
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00119315094
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00119413004
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00223200118
00223200128
00223200228
00223200301
00223200302
00223200303
00223200318
00223200418
00223200518
00223201113
00223202113
00223205018
00223205019
00223205020
00223205021
47223206000
47223206035
47223206055
47249134015
47249136015
47249140015
47249142015
47249144015
47249146015
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47249248110
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47249248113
47249248114
47349134009
47349134010
47349134011
47349134012
47349134013
47349134014
47349134015
47349136009
47349136010
47349136011
47349136012
47349136013
47349136014
47349136015
47349138009
47349138010
47349138011
47349138012
47349138013
47349138014
47349138015
47349140009
47349140010
47349140011
47349140012
47349140013
47349140014
47349140015
47349142009
47349142010
473491420 |
Code Information |
All products 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KTT
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