—#122425

Product

Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032473
Affected lot / code info: Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.

Why it was recalled

Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m

Root cause (FDA determination)

Device Design

Action the firm took

On 11/4/13, an URGENT MEDICAL DEVICE Recall Notification was sent to all domestic consignees via mail and foreign by email. An advisory was sent to every physician that uses any of the products listed. Every physician that uses any of these products must print their name and sign below which means you acknowledge that youve received a copy of the attached advisory and that you understand the information regarding the proper usage of the Decompressor. Once the form has been signed by all physicians, the form must be completed and signed by the recall coordinator. Please fax to 866-521-2762 or email to kara.spath@stryker.com.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.

Timeline

Recall initiated: 2013-11-04
Posted by FDA: 2013-11-01
Terminated: 2014-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122425. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.