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PERSONA Natural Tibia recallZ-1806-2018 · Zimmer Biomet, Inc. · initiated Aug 7, 2017

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

There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form and Attachment 3 Certificate of Decontamination to Zimmer Biomet. a. For each return, send a copy of Attachment 1 and Attachment 2 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen

Recall details

Recall number
Z-1806-2018
Status
Terminated
Initiated by the company
Aug 7, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
842 products in total
Product code
JWH
FDA submissions
K113369
Distribution
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.

Product description

Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.

Code information (models, lots, serial numbers)

Lot 63683139, UDI (01)00889024246942(10)63683139;  Lot 63613121, UDI (01)00889024246942(10)63613121

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

248 devices cleared under K113369 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 79991).

Sources and updates

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