—#132621

Product

Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.

FDA product code: OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K123459
Affected lot / code info: Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04: 42-5279-002-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 10mm; 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 12mm; 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 14mm; 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 10mm; 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 12mm; 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 14mm; 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 10mm; 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 12mm; 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 14mm; 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 10mm; 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 12mm; 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 14mm; 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 10mm; 42-5279-003-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 11mm; 42-5279-003-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 12mm; 42-5279-003-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 13mm; 42-5279-003-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 14mm; 42-5279-005-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 10mm; 42-5279-005-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 11mm; 42-5279-005-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 12mm; 42-5279-005-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 13mm; 42-5279-005-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 14mm; 42-5279-007-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 10mm; 42-5279-007-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 11mm; 42-5279-007-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 12mm; 42-5279-007-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 13mm; 42-5279-007-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 14mm.

Why it was recalled

Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy, Japan, Luxembourg, Netherlands, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2014-12-11
Posted by FDA: 2015-02-04
Terminated: 2015-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.