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U.S. Department of Health and Human Services

Class 2 Device Recall Solitaire35

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  Class 2 Device Recall Solitaire35 see related information
Date Initiated by Firm April 09, 2013
Date Posting Updated September 27, 2013
Recall Status1 Terminated 3 on June 17, 2014
Recall Number Z-2292-2013
Recall Event ID 65043
510(K)Number K093629  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Code Information 14-535140, 12 mm 6-deg narrow, 2327561 October-22, 2302271 April-22

14-535141, 14mm 6-deg narrow, 2327661 November-22, 2302281 April-22

14-535142 , 16mm 6-deg narrow, 2327691 December-22, 2302291 April-22

14-535143, 18 mm 6-deg narrow , 2327701 December-22, 2302301 April-22

14-535144 , 20mm 6-deg narrow, 2327711 December-22, 2302301 April-22

14-535144, 20 mm 6-deg narrow, 2302311 June-22

14-535150 , 12mm 12-deg narrow, 2327711 December-22, 2302321 April-22

14-535151, 14mm 12-deg narrow, 2327601 October-22, 2302332 April-22

14-535152, 16mm12-deg narrow , 2327671 November-22, 2302341 April-22

14-535153, 18 mm 12-deg narrow , 2327751 December-22, 2302351 April-22

14-535154, 20 mm 12-deg narrow, 2327571 December-22, 2327571 November-22, 2302361 April-22

14-535170, 12mm 6-deg medium , 2327631 October-22, 2302371 April-22

14-5351711 , 14 mm 6-deg medium, 2327641 October-22, 2302381 April-22

14-535172, 16 mm 6-deg medium, 2327761 December-22, 2302391 April-22

14-535173 , 18 mm 6-deg medium , 2327771 Dec 22, 2302401 April 22

14-535174 , 20 mm 6-deg medium, 2302411 April-22

14-535180, 12mm 12-deg medium, 2327621 October-22, 2302421 April-22

14-535180, 12 mm 12-deg medium, 2327621 October-22, 2302421 April-22

14-535182, 16mm 12-deg medium, 2327651 October 22, 2302441 April 22

14-535183 , 18 mm 12-deg medium , 2302451 April-22

14-535184, 20 mm 12-deg medium , 2327581 October-22, 2302461 April-22

14-535200, 12 mm 6-deg wide, 2302471 April-22

14-535201 , 14mm 6-deg wide, 2327721 December-22, 2302481 April-22

14-535202 , 16 mm 6-deg wide , 2327591 October-22, 2302491 March-22

14-535203, 18 mm 6-deg wide, 2328311 October-22, 2302501 April-12

14-535204 , 20 mm 6-deg wide, 2302511 April-22

, 14-535210, 12 mm 12 deg wide, 2302521 April 22

14-535211, 14 mm 12-deg wide, 2327681 Decembr-22, 2302531 April-22

14-535212, 16 mm 12-deg wide, 2327731 December-22, 2302541 April-22

14-535213, 18mm 12-deg wide, 2327741 December-22, 2302551 May-22.
Recalling Firm/
Manufacturer
Ebi, Llc
399 Jefferson Rd
Parsippany NJ 07054-3707
For Additional Information Contact Ms. Karen McCommons
973-299-9300 Ext. 3904
Manufacturer Reason
for Recall
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
FDA Determined
Cause 2
Process control
Action Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013.
Quantity in Commerce 1730 units
Distribution Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
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.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = BIOMET SPINE
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