FDA recall Z-0373-2019

Howmedica Osteonics Corp. · Class II · device

Product

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.

Reason for recall

Potential for outer pouch sterile barrier to be compromised

Distribution

US Nationwide in the states of AL, FL, IL, MI, NJ & OH.

Key facts

Status
Terminated
Initiation date
2018-09-10
Report date
2018-11-14
Termination date
2020-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0373-2019