Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0367-2017 — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100C

U.S. FDA — Device Enforcement · United States · 2016-08-02 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0367-2017
Date of alert
2016-08-02
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Greatbatch Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2233370001
Reported risk: On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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