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TEMA Elbow
LIMACORPORATE SPA · Model 1504.14.080 · UDI-DI 08033390140225
10
510(k) clearances
3,056
Adverse events (13 deaths)
20
Recalls
72
Facilities
Description
Humeral Stem H8 left
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-25 | Limacorporate S.p.A | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. |
| 2019-12-12 | Zimmer Biomet, Inc. | The lot contained two outer pins instead of one outer and one inner pin. |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2018-01-24 | Zimmer Biomet, Inc. | One lot of humeral stem implants do not include the humeral bushing components. |
| 2016-08-16 | Zimmer Biomet, Inc. | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was package |
| 2014-05-15 | Biomet, Inc. | Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience |
| 2012-11-19 | Zimmer, Inc. | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replac |
| 2012-11-19 | Zimmer, Inc. | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replac |
| 2011-12-14 | Biomet, Inc. | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles. |
| 2011-04-29 | Biomet, Inc. | The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.