Zimmer Recalls Persona Tibial Articular Surface Provisional Shims Due to Cleaning Defect
Zimmer, Inc. is recalling Persona Tibial Articular Surface Provisional Shims because repeated sonic cleaning can break the ball bearing retention feature, potentially leaving parts in the surgical wound.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (foreign objects left in a surgical wound) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling the Persona (TASP) Tibial Articular Surface Provisional Shim, including all sizes and lots from catalog numbers 42-5279-002-00 through 42-5279-009-04. The recall involves 67,963 units that were distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is due to a defect where repeated cycles of sonic cleaning can break down the ball bearing retention feature, known as a swage, on the shim. This failure creates a potential for delay in surgery and a risk that ball bearings could be left in the patient's wound. The source text specifies that to prevent this issue, the TASP shims must be manually cleaned and inspected according to the product insert 87-6203-991-22.
These instruments are intended for multiple uses and are used by surgeons to assess the thickness of the articular surface required during trial range of motion. The TASP construct consists of a bottom, a shim, and a top, with shims available in varying thicknesses to allow for trialing specific implant thicknesses.
The recalled product
- 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…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 67,963
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Persona (TASP) Tibial Articular Surface Provisional Shim
- CD
- 10mm
- 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 12mm
- 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 14mm
- 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- EF
- 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- GH
- 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- J
- 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim
- 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim
Distribution
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