—#176931

Product

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle

FDA product code: N/A
Affected lot / code info: Unknown

Why it was recalled

Modified outside of approved manufacturing process

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DePuy Synthes notified account by letter dated 10/4/19 stating reason for recall, health risk and action take: The modified instruments were removed from your facility on September 5, 2019. Please complete the Business Reply Form acknowledging that the modified instruments are not in the possession of your facility. Return the completed Business Reply Form to you sales consultant or email to DPYUS-SpineFieldActions@its.jnj.com within five (5) business days of this notice. Questions, or become aware of an adverse event associated with the subject devices, please call our Recall Hotline at 610-719-5450 (8 am 5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: AR

Timeline

Recall initiated: 2019-09-05
Terminated: 2020-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.