CLASS I Device recall · Reported 31 May 2017 · FDA Enforcement Report

10-1335M - SpF-XL IIB 2/DM Implantable Stimulator recalled

EBI Patient Care is recalling 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator, distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.

Quantity recalled33 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2118-2017
FDA event ID: 77089
Recalling firm: EBI Patient Care, Guaynabo, PR
Classification: Class I
Status: Terminated
Recall initiated: 20 Apr 2017
FDA classified: 25 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

20 Apr 2017	Recall initiated by company
25 May 2017	Classified by FDA	+35 days
31 May 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

Product as listed by the FDA

10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

Where it was distributed

Nationwide distribution only.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.

Where was it sold?

Nationwide distribution only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 77089

This product is part of a recall event; the main page for the event is 10-1398M - SpF-PLUS Implantable Stimulator recalled by EBI Patient Care.

Reported	Class	Recall	Company	Reason	Where
31 May 2017	CLASS I	10-1398M - SpF-PLUS Implantable Stimulator recalled by EBI Patient Care	EBI Patient Care	Other	Nationwide

More recalls from EBI Patient Care

All 2

Reported	Class	Recall	Company	Reason	Where
31 May 2017Device	CLASS I	10-1398M - SpF-PLUS Implantable Stimulator recalled by EBI Patient Care	EBI Patient Care	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide