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U.S. Department of Health and Human Services

Class 3 Device Recall Ruggles Leyla Ball Joint Clamp

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 Class 3 Device Recall Ruggles Leyla Ball Joint Clampsee related information
Date Initiated by FirmApril 24, 2006
Date PostedSeptember 16, 2006
Recall Status1 Terminated 3 on September 15, 2006
Recall NumberZ-1506-06
Recall Event ID 36031
Product Classification Ball joint clamp - Product Code FWZ
ProductRuggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.
Code Information The affected product can be identified by the following code on the product label: 143 60173 6.
FEI Number 2430952
Recalling Firm/
Manufacturer		 J. Jamner Surgical Instruments, Inc.
9 Skyline Drive
Hawthorne NY 10532-2100
For Additional Information ContactEric R. Gillman
609-936-2378
Manufacturer Reason
for Recall		The Ruggles Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move.
FDA Determined
Cause 2		Other
ActionOn 4/24/06, Integra LifeSciences Corp. sent an 'URGENT - RECALL NOTICE' letter (dated 4/24/06) and a 'RECALL ACKNOWLEDGEMENT' Form to the 5 hospitals and 1 salesman that received the product.
Quantity in Commerce8 units
Distribution5 hospitals in MS, IL, WI and TX, and 1 salesman in IL.
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.
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