Date Initiated by Firm | May 16, 2018 |
Date Posted | June 01, 2018 |
Recall Status1 |
Terminated 3 on April 05, 2024 |
Recall Number | Z-2242-2018 |
Recall Event ID |
80193 |
510(K)Number | K831005 |
Product Classification |
Pin, fixation, smooth - Product Code HTY
|
Product | 3.2MM X 560MM COCR THD TIP; 14-441053
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. |
Code Information |
631960 668040 668020 668030 668050 668060 265460 265450 322270 354190 370190 918470 034780 101840 216280 135720 327770 363260 389080 389070 399500 436760 436770 471160 471170 005620 244600 403100 791030 791110 839790 898930 898940 898960 974090 974100 974060 974070 974080 038580 142780 142790 492260 522530 205310 767140 492270 341690 620450 118270 418780 107090 373830 600950 609070 044210 044220 612900 683640 683630 507830 675290 284100 132110 962210 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 411 Technical Services 574-372-3071 |
Manufacturer Reason for Recall | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2018 on May 16, 2018, to affected consignees via email and FedEx. The letter describes the product, problem and actions to be taken. Consignees were informed of the recall and instructed to take the following actions:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com
b. International returns, please request an IRA by emailing zimmerbiometintlirarequests@zimmerbiomet.com
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall.
b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format |
Quantity in Commerce | 2396 |
Distribution | Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands. |
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 = HTY
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