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FDA (Device enforcement)Recalled 2013-06-10closedclass ii

Zimmer, Inc.: Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

Is my product affected?

Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

  • UPC 42517000410

Check against the official notice below — it lists the full affected range.

What happened

Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) used during knee replacement surgery planning. The company received complaints about breakage of these trial components, which are temporary devices used to test fit and function before permanent implant placement. The recall was initiated to address corrective actions Zimmer had already taken earlier in the year regarding these products.

The affected devices were distributed worldwide to locations across the United States, Puerto Rico, Washington DC, and several international countries including Canada, Australia, Germany, Japan, India, Korea, and Singapore. A total of 70,986 distribution events involved specific lot numbers ranging from 62024975 to 62717346, all under item number 42517000410. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Details from the source

Reason for recall: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore. Quantity: 70,986 distribution events Lot/code info: Item Numbers: 42517000410 Lot Numbers: 62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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