XRL 03.807.330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034723181), received between May 29, 2018 and May 29, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K103320); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LATERAL SPINAL FUSION PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THE WRONG SIZED XRL SHAFT WAS INSERTED IN AN EVALUATION SET. THE SALES CONSULTANT STATED HE ORDERED TWO SETS WITH DIFFERENT SIZED SHAFTS, ONE A MEDIUM AND THE OTHER A LARGE. THE SURGEON WAS UNSURE IF A MEDIUM OR A LARGE WOULD BE NEEDED IN THE PROCEDURE. HOWEVER, ONCE THE SURGERY BEGUN, IT WAS CONFIRMED THAT A MEDIUM SHAFT WOULD BE NEEDED. THE SALES CONSULTANT OPENED THE MEDIUM SET AND PREPARED IT FOR USE (ATTACHING THE SPREADER TO THE SHAFT AND INSERTING THE IMPLANT). ALMOST INSTANTLY, THE IMPLANT FELL OUT OF THE SHAFT. THE SHAFT WAS TOO BIG TO HOLD THE SMALLER IMPLANT, BECAUSE IT WAS A LARGE SHAFT AND NOT A MEDIUM SHAFT. THE SALES CONSULTANT DECIDED TO OPEN THE LARGE SET IN HOPES THAT THE TWO WERE SWAPPED; BUT, THEY WERE NOT. THIS INCORRECT SET CAUSED AN ESTIMATED 10-MINUTE DELAY IN SURGERY AS THE SURGEON ATTEMPTED TO FIND ANOTHER WAY TO COMPLETE THE SURGERY WITHOUT USING THE ORIGINALLY PLANNED IMPLANT. THE SURGEON DECIDED TO IMPLANT THE PATIENT WITH AN AVAILABLE NON-SYNTHES CAGE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING TH

  Patient problems: No Code Available

  MAUDE report 7549056 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103320. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2014 · Apr 8, 2014 · Terminated
  Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is