Vitality® 07.02000.118Recalls & reported problems

All models of Vitality (38)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 17
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024002159), received between Oct 6, 2023 and Oct 16, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 16, 2023Class IIOpen, Classified
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
Z-0639-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Inaccurate Information17

Patient problems

No Clinical Signs, Symptoms or Conditions17

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT SEVEN OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942738 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT SIX OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942688 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT FIVE OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942537 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT FOUR OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942418 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT THREE OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942350 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT TWO OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942327 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THE LENGTH OF THE SIZE LASER MARKED ON SEVEN VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT ONE OF SEVEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942104 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON TWO VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940798 ↗
MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON TWO VITALITY SCREWS DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND IN A WAREHOUSE AND DID NOT HAVE ANY PATIENT INVOLVEMENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940796 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT.THIS IS REPORT EIGHT OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890657 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT SEVEN OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890650 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT SIX OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890617 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT.THIS IS REPORT FIVE OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890614 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT.THIS IS REPORT FOUR OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890586 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT THREE OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890544 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT TWO OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890520 ↗
MalfunctionOct 6, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE LENGTH OF THE SIZE LASER MARKED ON A VITALITY SCREW DOES NOT MATCH THE SIZE THAT CORRELATES WITH THE LASER MARKED PART NUMBER. THE LASER MARKED PART NUMBER IS 07.02000.118, WHICH SHOULD BE A 7.5 X 50 SCREW. HOWEVER, THE SIZE IS LASER MARKED 7.5 X 40MM. THIS WAS FOUND DISCOVERED IN THE STERILE DEPARTMENT WHEN PLACING THE SCREW INTO THE STERILIZATION CADDY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT ONE OF EIGHT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890490 ↗

Device details

UDI-DI	`00889024002159`
Brand	Vitality®
Model	07.02000.118
Company	Biomet Spine LLC
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Bone-screw internal spinal fixation system, non-sterile

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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