Recalls / —

—#163239

Product

Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set

FDA product code

FSM — Tray, Surgical, Instrument

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

FL00860

Why it was recalled

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Root cause (FDA determination)

Process control

Action the firm took

On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, 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

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

Timeline

Recall initiated

2018-03-05

Terminated

2020-02-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #163239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.