Reported Dec 19, 2018 · Terminated
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
- Lot codes and dates
- UDI
110 of 110 codes
07613327117943All lotsModel Numbers 48950070489500764895008048950086489500904895009648950100489501064895011048950116489501204895012648950130489501364895014048950146489510704895107648951080489510864895109048951096489511004895110648951110489511164895112048951126489511304895113648951140489511464895207048952080489520904895210048952110489521204895213048952140489530704895308048953090489531004895311048953120489531304895314048954076489540864895409648954106489541164895412648954136489541464895507648955086
- UDI
- Amount recalled
- 28,461
Where it was sold
- Nationwide
Why it was recalled
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Howmedica Osteonics Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.