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SMR Shoulder system
LIMACORPORATE SPA · Model 9013.50.211 · UDI-DI 08033390098007
HXC
Prescription
6
510(k) clearances
1,571
Adverse events (1 deaths)
8
Recalls
266
Facilities
Description
Allen Wrench Dia. 3,5 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-08-14 | New Standard Device Inc | Due to manufacturing processing error, wrench causing stripping when torqueing nuts. |
| 2016-01-08 | Orthofix, Inc | There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value ma |
| 2015-07-07 | Aesculap, Inc. | A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions |
| 2015-03-12 | Biomet Spine, LLC | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates o |
| 2015-03-12 | Biomet Spine, LLC | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates o |
| 2015-02-02 | Bradshaw Medical Inc. | A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. |
| 2012-07-24 | DePuy Spine, Inc. | A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specificat |
| 2008-11-07 | Zimmer Inc. | Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique. |
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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.