Z-2292-2013Class II

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

Name: Z-2292-2013 Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device
Creator: Ebi, Llc
Published: 2013-04-09
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2013-04-09 / Terminated / root cause: manufacturing process

FDA source

Ebi, Llc began a recall of Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device on 2013-04-09. FDA classified it as Class II and gives the reason as "Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2292-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-09
Posted: 2013-09-27
Terminated: 2014-06-17
Recalling firm: Ebi, LLC
Product: Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-27

Product code MAX

K093629Class IISolitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine / cleared 2010-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)