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Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem… recallZ-1191-2018 · Zimmer Biomet, Inc. · initiated Mar 1, 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

Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

FDA root cause category: Labeling mix-ups

What the company is doing

RISK MANAGER: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to [email protected]. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents. 2. Quarantine affected product in your inventory. 3. Return affected product from your distributorship and from affected hospitals. a. Complete Inventory Return Certification Form and send to [email protected] Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected].

Recall details

Recall number
Z-1191-2018
Status
Terminated
Initiated by the company
Mar 1, 2018
Posted by the FDA
Mar 14, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
12
Product code
LPH
FDA submissions
K032726
Distribution
Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.

Product description

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40

Code information (models, lots, serial numbers)

Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611

Devices named in this recall

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

Other devices under the same FDA submission

26 devices cleared under K032726 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 79406).

Sources and updates

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