Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Reliance LITe Nerve Hook Bayoneted

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Reliance LITe Nerve Hook Bayonetedsee related information
Date Initiated by FirmNovember 26, 2018
Create DateDecember 21, 2018
Recall Status1 Terminated 3 on May 26, 2020
Recall NumberZ-0657-2019
Recall Event ID 81645
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductReliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.
Code Information Lot #s 183432, 183433, 183434, 17E168
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactChrista Joisil
201-749-8268
Manufacturer Reason
for Recall		Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, Stryker, sent an "Urgent Medical Device Recall" letter dated 11/14/2018 to its customers on 11/26/2018. The letter described product, problem and actions to be taken. The customers were instructed to: Examine your inventory; Immediately quarantine the affected product; and complete customer response form to Stryker Spine at email: Spine-RegulatoryAction@stryker.com. For questions contact Manager-Regulatory Compliance & Quality System at 866-45-SPINE (77463)..
Quantity in Commerce39
DistributionWorldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-