—#122358

Product

Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.

FDA product code: OAR — Injector, Vertebroplasty (Does Not Contain Cement)
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part No. 03.702.218S, Lot No. AJM838X

Why it was recalled

Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution including IN, MT, HI, and FL.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-11-27
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.