Synthes (USA) Products LLC 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Modified outside of approved manufacturing process

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AR