CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report

Tritanium Posterior Lumbar (PL) cage intervertebral body recalled

Howmedica Osteonics is recalling Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant, distributed nationwide in the US. The recall was initiated on 28 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950106, 48950110, 48950116,48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090,48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126,48951130, 48951136,48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130,48952140,48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076,48954086, 48954096,48954106,48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132,48956086,48956096,48956106, 48956116, 48956126,48956136, 48956146,48956140,48957092,48957112, 48957132, 48956112, 48956132, 48952092,48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076,48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142

Quantity recalled28,461

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-0605-2019
FDA event ID: 81587
Recalling firm: Howmedica Osteonics, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2018
FDA classified: 13 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

28 Nov 2018	Recall initiated by company
13 Dec 2018	Classified by FDA	+15 days
19 Dec 2018	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

The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.

Product as listed by the FDA

Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.

Which lots are affected?

UDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950106, 48950110, 48950116,48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090,48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126,48951130, 48951136,48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130,48952140,48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076,48954086, 48954096,48954106,48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132,48956086,48956096,48956106, 48956116, 48956126,48956136, 48956146,48956140,48957092,48957112, 48957132, 48956112, 48956132, 48952092,48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076,48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142

Where was it sold?

US Nationwide

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Howmedica Osteonics

All 232

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
31 Dec 2025Device	CLASS II	The Stryker CranialMask Tracker is a single-use device recalled	Howmedica Osteonics	Device Malfunction	Nationwide
8 Oct 2025Device	CLASS II	Exeter V40 Stem No recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	NJ

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