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U.S. Department of Health and Human Services

Class 2 Device Recall Solitaire35

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 Class 2 Recall
Solitaire35
see related information
Date Posted September 27, 2013
Recall Status1 Terminated on June 17, 2014
Recall Number Z-2292-2013
Recall Event ID 65043
Premarket Notification
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, New Jersey 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = BIOMET SPINE
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