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Comprehensive Reverse Shoulder recallZ-0093-2021 · Biomet, Inc. · initiated Sep 2, 2020

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 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

Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

FDA root cause category: Packaging process control

What the company is doing

Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed 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].

Recall details

Recall number
Z-0093-2021
Status
Terminated
Initiated by the company
Sep 2, 2020
Recalling firm
Biomet, Inc.
Quantity
3 units
Product code
PHX
FDA submissions
K120121, K193373
Distribution
US Nationwide distribution including in the states of CO, MN, OH, WY.

Product description

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Code information (models, lots, serial numbers)

Lot Numbers:  488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and  564110- UDI (01) 00880304532465 (17) 300609 (10) 564110

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

46 devices cleared under K120121, K193373 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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