Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the

FDA device recall Z-2260-2024 · posted 2024-07-03 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

Reason for recall

Expired Products distributed to customers

Action taken

Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to Instruments.recalls@stryker.com, even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be shipped promptly. 4. Maintain awareness of this communication internally and inform Stryker if any of the devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Lacey Marshall at 269-270-5950 or Instruments.recalls@stryker.com with questions or concerns.

Root cause

Storage

Status

Open, Classified

Product code

OAR

Quantity affected

3 units

Distribution

US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

Date initiated

2024-06-03

Date posted

2024-07-03

Location

Portage, MI