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Bead Tip Gd Wire 3.0mm X 60cm recallZ-2239-2018 · Zimmer Biomet, Inc. · initiated May 16, 2018

Class II Terminated All recalls posted in June 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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 [email protected] b. International returns, please request an IRA by emailing [email protected] 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 [email protected]. 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

Recall details

Recall number
Z-2239-2018
Recall class
Class II
Status
Terminated
Initiated by the company
May 16, 2018
Posted by the FDA
Jun 1, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
2168
Product code
HTY
FDA submissions
K831005
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.

Product description

BEAD TIP GD WIRE 3.0MM X 60CM; 29402 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 (models, lots, serial numbers)

563080 563090 407870 408160 408140 412690 412750 412720 412740 668840 202750 389030 410170 410180 395170 513920 201790 232930 639560 800410 980930 134560 271820 351760 504870 578400 605700 750960 750970 913730 921150 058010 631570 969080 101380 944200 969090 203000 449730 449740 449750 449720 665510 820130 850170 978340 221240 419010 848820 848810 278720 387620 437340 502200 623450 038560 186020 212630 183170 183180 183190 434630 183200 930950 693480

Other devices under the same FDA submission

2 devices cleared under K831005 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80193).

Sources and updates

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