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ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and pati...

FDA Device Recall #Z-2700-2015 — Class II — July 10, 2015

Recall Summary

Recall Number Z-2700-2015
Classification Class II — Moderate risk
Date Initiated July 10, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Customed, Inc
Location Fajardo, PR
Product Type Devices
Quantity 639

Product Description

ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Reason for Recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Distribution Pattern

Distributed Only in Puerto Rico.

Lot / Code Information

Code:900741A Lots: 140915516 exp. 11/30/15 150116509 exp. 12/31/15 150116510 exp. 12/31/15 150317657 exp. 3/31/16 150318094 exp. 3/31/16 150318095 exp. 3/31/16 150318197 exp. 4/30/16 150318196 exp. 4/30/16 150318198 exp. 4/30/15 150518839 exp. 5/31/16 150619189 exp. 6/30/16 150619406 exp. 6/30/16

Other Recalls from Customed, Inc

Recall # Classification Product Date
Z-1458-2016 Class II Catalog Number: 900277 SUCTION CATHETER TRAY ... Jan 7, 2016
Z-1464-2016 Class II Catalog Number: 9002940 OBSTETRICAL SURGICAL ... Jan 7, 2016
Z-1398-2016 Class II Catalog Number: 900010 SUTURE REMOVAL KIT Use... Jan 7, 2016
Z-1439-2016 Class II Catalog Number: 9001933 OPHTALMIC SURGICAL PA... Jan 7, 2016
Z-1433-2016 Class II Catalog Number: 900169 UNIVERSAL SURGICAL PAC... Jan 7, 2016

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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