Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
This recall has been terminated (originally issued September 27, 2013).
- Company
- Ebi, Llc
- Recall Initiated
- April 9, 2013
- Posted
- September 27, 2013
- Terminated
- June 17, 2014
- Recall Number
- Z-2292-2013
- Quantity
- 1730 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Distribution
Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.