—#151426

Product

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

FDA product code: FSM — Tray, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog ID (part # 60.119.012), Lot Number FL00528

Why it was recalled

The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: Synthes5748@stericycle.com or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-11-29
Posted by FDA: 2016-12-21
Terminated: 2017-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151426. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.