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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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  Class 2 Device Recall ORTHOPEDIC MANUAL SURGICAL INSTRUMENT see related information
Date Initiated by Firm September 08, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on July 31, 2018
Recall Number Z-0810-2018
Recall Event ID 79147
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product AccuLIF TL Insertion Handle

The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
Code Information Model# 800804 Lot numbers 160010 and 170003
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact
201-760-8000
Manufacturer Reason
for Recall		 When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
FDA Determined
Cause 2		 Under Investigation by firm
Action A recall letter, dated August 25, 2017, titled "Product Recall Re: AccuLIFTL Insertion Handle" instructing customers to meet with the Stryker Representative issuing the letter, complete the requested form and return any affected product to this representative. Questions or concerns can be directed to Customer Service at 201-749-8699
Quantity in Commerce 130
Distribution Nationally
Total Product Life Cycle TPLC 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.
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