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Terminated

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

FDA Recall Z-1191-2018 · Posted 2018-03-14

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2018-03-01
Date Terminated2019-07-18
Product Quantity12

Reason for Recall

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.

Firm Action

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].

Root Cause

Labeling mix-ups

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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