Recalls / —

—#150555

Product

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

FDA product code

HTO — Reamer

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049

Why it was recalled

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.

Recalling firm

Firm

Synthes (USA) Products LLC

Address

1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern

Distributed Nationwide

Timeline

Recall initiated

2016-10-03

Posted by FDA

2016-11-19

Terminated

2017-07-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #150555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.