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Gentle Threads recallZ-3176-2018 · Zimmer Biomet, Inc. · initiated Jul 20, 2018

Terminated

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 Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

FDA root cause category: Process control

What the company is doing

On 7/20/18, Urgent Medical Device Recall notification letters were sent to customers. The letters instructed customers to do the following: Risk Managers: 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. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call 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 [email protected]. Surgeons: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call 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 tra

Recall details

Recall number
Z-3176-2018
Status
Terminated
Initiated by the company
Jul 20, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
52
Product code
HWC
FDA submissions
K982497
Distribution
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Product description

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Code information (models, lots, serial numbers)

Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

5 devices cleared under K982497 are not named by identifier in this recall. 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 80843).

Sources and updates

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