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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 Posted September 27, 2013
Recall Status1 Terminated 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 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.
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