Home / Recalls / Ebi, Llc / Z-2292-2013

Z-2292-2013 Class II Terminated

Recalled by Ebi, Llc — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
October 9, 2013
Initiation Date
April 9, 2013
Termination Date
June 17, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1730 units

Product Description

Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

Reason for Recall

Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

Distribution Pattern

Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.

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

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