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SMR Shoulder

LIMACORPORATE SPA · Model Reamer · UDI-DI 08033390095167

KWT KWS Prescription

510(k) clearances

5,649

Adverse events (12 deaths)

Recalls

154

Facilities

Description

Reamer SMALL-R #X-LONG

Recalls

Date	Firm	Reason
2023-11-21	Exactech, Inc.	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2019-10-10	Zimmer Biomet, Inc.	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2019-10-10	Zimmer Biomet, Inc.	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2019-10-10	Zimmer Biomet, Inc.	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2018-08-21	Exactech, Inc.	The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
2018-02-28	Biomet, Inc.	During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw
2017-06-05	Zimmer Biomet, Inc.	Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label c
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2016-10-25	Exactech, Inc.	Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
2015-08-14	Limacorporate S.p.A	The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

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Data 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.