BALL NOSE GUIDE WIRE recallZ-0531-2020 · Zimmer Biomet, Inc. · initiated Aug 21, 2019

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

FDA root cause category: Environmental control

What the company is doing

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 [email protected]. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.

Recall details

Recall number

Z-0531-2020

Status

Terminated

Initiated by the company

Aug 21, 2019

Recalling firm

Zimmer Biomet, Inc.

Quantity

2708

Product code

FZX

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BALL NOSE GUIDE WIRE 2810-17-006

  Biomet Orthopedics, LLC · Guide, surgical, instrument
  1 recall0 reports

Product lines

• BALL NOSE GUIDE WIREBiomet Orthopedics, LLC · 3 models · 4 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 83783).

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• Z-0523-2020 · Terminated
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• Z-0526-2020 · Terminated
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• Z-0527-2020 · Terminated
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• Z-0528-2020 · Terminated
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• Z-0529-2020 · Terminated
  GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical de…
• Z-0530-2020 · Terminated
  BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical dev…
• Z-0533-2020 · Terminated
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