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Class 2 Device Recall VERSANAIL |
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| Date Initiated by Firm |
August 21, 2019 |
| Create Date |
November 22, 2019 |
| Recall Status1 |
Terminated 3 on July 21, 2021 |
| Recall Number |
Z-0531-2020 |
| Recall Event ID |
83783 |
| Product Classification |
Guide, surgical, instrument - Product Code FZX
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| Product |
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
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| Code Information |
LOTS: 206322 062980 062690 062720 062740 062760 062950 062960 062970 730390 730400 730380 158530 158510 158520 460220 859610 860250 661640 977840 977850 114600 167450 204150 204160 204180 204190 204200 204210 678430 491410 678420 233730 233770 392590 233710 233720 694090 039330 039340 039350 039360 039370 039380 039450 039420 039390 039400 039410 039430 039440 039460 039470 113340 994740 036320 036330 665740 994730 036290 204970 204990 205000 205010 205020 472130 164579 164582 164586 164587 206318 206319 206320 206321 260820 260821 270166 270167 AF6AE7000 AT9AG7 B5KAT7 B5LAA7 B78AE7 B78AF7 BD3AA7 BT9AD7 BX2AB7 CN8AG7 CN8AH7 CW3AT7 CW3AV7 CW3AV7R CW3AW7 CW3AW7R CW3AX7 E3SAB7 E3SAC7 EG9AF7 EG9AG7 EG9AH7 EG9AJ7 NXW351U NXW351V UDI: (01)00887868029448(17)220501(10)206322 (01)00887868029448(17)240819(10)062980 (01)00887868029448(17)240819(10)062690 (01)00887868029448(17)240819(10)062720 (01)00887868029448(17)240819(10)062740 (01)00887868029448(17)240819(10)062760 (01)00887868029448(17)240819(10)062950 (01)00887868029448(17)240819(10)062960 (01)00887868029448(17)240819(10)062970 (01)00887868029448(17)241013(10)730390 (01)00887868029448(17)241013(10)730400 (01)00887868029448(17)241013(10)730380 (01)00887868029448(17)241101(10)158530 (01)00887868029448(17)241103(10)158510 (01)00887868029448(17)241103(10)158520 (01)00887868029448(17)241201(10)460220 (01)00887868029448(17)250115(10)859610 (01)00887868029448(17)250116(10)860250 (01)00887868029448(17)250410(10)661640 (01)00887868029448(17)250429(10)977840 (01)00887868029448(17)250429(10)977850 (01)00887868029448(17)250601(10)114600 (01)00887868029448(17)250601(10)167450 (01)00887868029448(17)250921(10)204150 (01)00887868029448(17)250921(10)204160 (01)00887868029448(17)250921(10)204180 (01)00887868029448(17)250921(10)204190 (01)00887868029448(17)250922(10)204200 (01)00887868029448(17)250922(10)204210 (01)00887868029448(17)260614(10)678430 (01)00887868029448(17)260623(10)491410 (01)00887868029448(17)260108(10)678420 (01)00887868029448(17)260111(10)233730 (01)00887868029448(17)260111(10)233770 (01)00887868029448(17)260616(10)392590 (01)00887868029448(17)260111(10)233710 (01)00887868029448(17)260111(10)233720 (01)00887868029448(17)260403(10)694090 (01)00887868029448(17)260502(10)039330 (01)00887868029448(17)260502(10)039340 (01)00887868029448(17)260502(10)039350 (01)00887868029448(17)260502(10)039360 (01)00887868029448(17)260505(10)039370 (01)00887868029448(17)260505(10)039380 (01)00887868029448(17)260524(10)039450 (01)00887868029448(17)260525(10)039420 (01)00887868029448(17)260525(10)039390 (01)00887868029448(17)260525(10)039400 (01)00887868029448(17)260525(10)039410 (01)00887868029448(17)260525(10)039430 (01)00887868029448(17)260525(10)039440 (01)00887868029448(17)260525(10)039460 (01)00887868029448(17)260525(10)039470 (01)00887868029448(17)260610(10)113340 (01)00887868029448(17)260610(10)994740 (01)00887868029448(17)260623(10)036320 (01)00887868029448(17)260623(10)036330 (01)00887868029448(17)260623(10)665740 (01)00887868029448(17)260623(10)994730 (01)00887868029448(17)260701(10)036290 (01)00887868029448(17)260718(10)204970 (01)00887868029448(17)260718(10)204990 (01)00887868029448(17)260718(10)205000 (01)00887868029448(17)260718(10)205010 (01)00887868029448(17)260718(10)205020 |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
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| For Additional Information Contact |
411 Technical Services
574-371-3071
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Manufacturer Reason
for Recall |
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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FDA Determined
Cause 2 |
Environmental control |
| Action |
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue.
Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties.
If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, 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.
There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. |
| Quantity in Commerce |
2708 |
| Distribution |
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. |
| 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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